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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001518-40 | EudraCT Number | ||
| U1111-1255-4378 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric participants with moderate to severe atopic dermatitis (AD) treated with dupilumab.
Secondary Objectives:
Total study duration including screening and follow-up was 32 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atopic Dermatitis Participants | Experimental | Pediatric participants with moderate-to-severe atopic dermatitis (AD) and with baseline body weight more than or equal to (>=) 15 kilograms (kg) and less than (<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 weeks (Q4W), from Week 4 to Week 12. Pediatric participants with body weight >=30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 weeks (Q2W), from Week 2 to Week 14. |
|
| Healthy Volunteers | No Intervention | Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab SAR231893 | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at Baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM. |
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Inclusion criteria :
Atopic dermatitis participants:
Healthy volunteers:
- Age and gender matched (match on age ±2 years) to a selected AD participant by study site.
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :8400002 | Los Angeles | California | 90027 | United States | ||
| Investigational Site Number :8400001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41611123 | Derived | Cork MJ, Ong PY, Danby SG, Byers RA, Matcher SJ, Katibi OS, Brown K, Andrew PV, Pinnock A, Poyner A, Johnson L, Gormley S, Hyde A, Ramirez-Gama M, Garcia S, Taylor PA, Bologna G, Praestgaard AH, Zahn J, Zhang A, Leung DYM. Dupilumab treatment restores epithelial barrier in nonlesional and lesional skin in children with atopic dermatitis. Ann Allergy Asthma Immunol. 2026 May;136(5):558-564.e3. doi: 10.1016/j.anai.2026.01.008. Epub 2026 Jan 27. |
| Label | URL |
|---|---|
| LPS16764 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Healthy volunteer's cohort received no treatment and was considered as a reference comparator group.
Study was conducted at 3 active sites in the United States and United Kingdom. A total of 43 participants were screened between 19 Feb 2021 and 12 May 2022, out of which 41 were enrolled and 2 were screen failures due to not meeting inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected atopic dermatitis (AD) participants, received no treatment, but were monitored in a similar way as AD participants. |
| FG001 | Atopic Dermatitis Participants | Pediatric participants with moderate-to-severe AD and with baseline body weight more than or equal to (>=) 15 kilograms (kg) and less than (<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 weeks (Q4W), from Week 4 to Week 12. Pediatric participants with body weight >=30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 weeks (Q2W), from Week 2 to Week 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis was performed on modified intent-to-treat (mITT) population which included all enrolled AD participants who received at least 1 dose of investigational medicinal product (IMP) and all enrolled healthy volunteers who had at least 1 TEWL/STS assessment performed, irrespective of compliance with protocol and procedures. If prohibited therapies used for AD, only visits prior to rescue treatment were considered.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants. |
| BG001 | Atopic Dermatitis Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for Healthy Volunteer arm as pre-specified in protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., up to Day 197)
Analysis was performed on safety population that included all participants, who actually received at least 1 dose of IMP or had at least 1 TEWL/STS assessment and all healthy volunteers who have at least 1 TEWL/STS assessment performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2020 | Aug 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2022 | Aug 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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| Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that was used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline ('predefined skin area'). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM. | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
| Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM. | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
| Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM. | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
| Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM. | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
| Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM. | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
| Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM. | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
| Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS (nsts) used to reflect the overall integrity of stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM. | Baseline, Days 57, 113 and 197 |
| Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS reflect the overall integrity of the stratum corneum. Non-LS areas for TEWL assessment & STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before & after 5, 10, 15 &20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Non-LS areas for TEWL assessment and STS were identified at baseline(predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10,15 and 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline(Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM. | Baseline, Days 57, 113 and 197 |
| Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over a defined number of STS used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment & STS were identified at baseline(predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10,15 & 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC: composite measure before & after 5, 10, 15& 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 conducted on first spot. Percent Change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM. | Baseline, Days 57, 113 and 197 |
| Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Normal skin areas for TEWL assessment and STS identified at baseline(predefined skin area). Within predefined Normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS and after 5, 10,15 and 20 STS on pre-defined Normal skin areas at specified time points. TEWL AUC was a composite measure before and after 5, 10,15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM. | Baseline, Days 57, 113 and 197 |
| Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participant were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participants were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on the first spot. Absolute change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Baseline, Days 57, 113 and 197 |
| Denver |
| Colorado |
| 80206 |
| United States |
| Investigational Site Number :8260001 | Sheffield | S10 2TH | United Kingdom |
Pediatric participants with moderate-to-severe AD and with baseline body weight >=15 kg and <30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight >=30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Atopic Dermatitis Participants | Pediatric participants with moderate-to-severe AD and with baseline body weight >=15 kg and <30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight >=30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14. |
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| Secondary | Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at Baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that was used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participants arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline ('predefined skin area'). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
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| Secondary | Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
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| Secondary | Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
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| Secondary | Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
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| Secondary | Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
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| Secondary | Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 |
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| Secondary | Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 57, 113 and 197 |
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| Secondary | Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS (nsts) used to reflect the overall integrity of stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | nsts*grams per square meter per hour | Baseline, Days 57, 113 and 197 |
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| Secondary | Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS reflect the overall integrity of the stratum corneum. Non-LS areas for TEWL assessment & STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before & after 5, 10, 15 &20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 57, 113 and 197 |
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| Secondary | Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Non-LS areas for TEWL assessment and STS were identified at baseline(predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10,15 and 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline(Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | nsts*grams per square meter per hour | Baseline, Days 57, 113 and 197 |
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| Secondary | Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over a defined number of STS used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment & STS were identified at baseline(predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10,15 & 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC: composite measure before & after 5, 10, 15& 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 conducted on first spot. Percent Change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 57, 113 and 197 |
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| Secondary | Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Normal skin areas for TEWL assessment and STS identified at baseline(predefined skin area). Within predefined Normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS and after 5, 10,15 and 20 STS on pre-defined Normal skin areas at specified time points. TEWL AUC was a composite measure before and after 5, 10,15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | nsts*grams per square meter per hour | Baseline, Days 57, 113 and 197 |
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| Secondary | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participant were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 57, 113 and 197 |
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| Secondary | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Days 57, 113 and 197 |
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| Secondary | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 57, 113 and 197 |
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| Secondary | Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on the first spot. Absolute change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Days 57, 113 and 197 |
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| Secondary | Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 57, 113 and 197 |
|
|
|
| Secondary | Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 | TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Days 57, 113 and 197 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 6 |
| 18 |
| EG001 | Atopic Dermatitis Participant | Pediatric participants with moderate-to-severe AD and with baseline body weight >=15 kg and <30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight >=30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14. | 0 | 23 | 0 | 23 | 21 | 23 |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Dermatitis Infected | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Gastrointestinal Viral Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Impetigo | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Molluscum Contagiosum | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Otitis Media Chronic | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Skin Bacterial Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Suspected Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Food Allergy | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eye Irritation | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Ocular Hyperaemia | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Medical Device Site Haemorrhage | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Tendon Injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Day 8 - Spot 3 |
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| Day 29 - Spot 1 |
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| Day 43 - Spot 1 |
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| Day 57 - Spot 1 |
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| Day 57 - Spot 2 |
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| Day 57 - Spot 3 |
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| Day 85 - Spot 1 |
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| Day 85 - Spot 2 |
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| Day 85 - Spot 3 |
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| Day 113 - Spot 1 |
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| Day 113 - Spot 2 |
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| Day 113 - Spot 3 |
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| Day 155 - Spot 1 |
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| Day 155 - Spot 2 |
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| Day 155 - Spot 3 |
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| Day 197 - Spot 1 |
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| Day 197 - Spot 2 |
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| Day 8 - Spot 3 |
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| Day 57 - Spot 1 |
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| Day 85 - Spot 1 |
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| Day 113 - Spot 1 |
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| Day 155 - Spot 1 |
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| Day 155 - Spot 3 |
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| Day 197 - Spot 1 |
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| Day 197 - Spot 2 |
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| Day 197 - Spot 3 |
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| Day 8 - Spot 3 |
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| Day 15 - Spot 1 |
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| Day 22 - Spot 1 |
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| Day 29 - Spot 1 |
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| Day 43 - Spot 1 |
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| Day 43 - Spot 2 |
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| Day 43 - Spot 3 |
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| Day 57 - Spot 1 |
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| Day 57 - Spot 3 |
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| Day 85 - Spot 1 |
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| Day 85 - Spot 3 |
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| Day 113 - Spot 1 |
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| Day 113 - Spot 2 |
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| Day 113 - Spot 3 |
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| Day 155 - Spot 1 |
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| Day 155 - Spot 2 |
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| Day 155 - Spot 3 |
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| Day 197 - Spot 1 |
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| Day 197 - Spot 2 |
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| Day 197 - Spot 3 |
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| Day 8 - Spot 3 |
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| Day 15 - Spot 1 |
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| Day 15 - Spot 2 |
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| Day 15 - Spot 3 |
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| Day 22 - Spot 2 |
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| Day 29 - Spot 1 |
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| Day 29 - Spot 2 |
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| Day 29 - Spot 3 |
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| Day 43 - Spot 1 |
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| Day 43 - Spot 2 |
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| Day 43 - Spot 3 |
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| Day 57 - Spot 1 |
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| Day 57 - Spot 2 |
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| Day 57 - Spot 3 |
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| Day 85 - Spot 1 |
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| Day 85 - Spot 2 |
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| Day 85 - Spot 3 |
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| Day 113 - Spot 1 |
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| Day 113 - Spot 2 |
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| Day 113 - Spot 3 |
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| Day 155 - Spot 1 |
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| Day 155 - Spot 2 |
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| Day 155 - Spot 3 |
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| Day 197 - Spot 1 |
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| Day 197 - Spot 2 |
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| Day 197 - Spot 3 |
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| Day 8 - Spot 3 |
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| Day 15 - Spot 1 |
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| Day 15 - Spot 2 |
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| Day 15 - Spot 3 |
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| Day 22 - Spot 1 |
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| Day 22 - Spot 2 |
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| Day 22 - Spot 3 |
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| Day 29 - Spot 1 |
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| Day 29 - Spot 2 |
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| Day 29 - Spot 3 |
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| Day 43 - Spot 1 |
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| Day 43 - Spot 2 |
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| Day 43 - Spot 3 |
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| Day 57 - Spot 1 |
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| Day 57 - Spot 2 |
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| Day 57 - Spot 3 |
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| Day 85 - Spot 1 |
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| Day 85 - Spot 2 |
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| Day 85 - Spot 3 |
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| Day 113 - Spot 1 |
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| Day 113 - Spot 2 |
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| Day 113 - Spot 3 |
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| Day 155 - Spot 1 |
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| Day 155 - Spot 2 |
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| Day 155 - Spot 3 |
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| Day 197 - Spot 1 |
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| Day 197 - Spot 2 |
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| Day 197 - Spot 3 |
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| Day 8 - Spot 3 |
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| Day 15 - Spot 1 |
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| Day 15 - Spot 2 |
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| Day 15 - Spot 3 |
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| Day 22 - Spot 1 |
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| Day 22 - Spot 2 |
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| Day 22 - Spot 3 |
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| Day 29 - Spot 1 |
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| Day 29 - Spot 2 |
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| Day 29 - Spot 3 |
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| Day 43 - Spot 1 |
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| Day 43 - Spot 2 |
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| Day 43 - Spot 3 |
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| Day 57 - Spot 1 |
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| Day 57 - Spot 2 |
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| Day 57 - Spot 3 |
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| Day 85 - Spot 1 |
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| Day 85 - Spot 2 |
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| Day 85 - Spot 3 |
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| Day 113 - Spot 1 |
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| Day 113 - Spot 2 |
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| Day 113 - Spot 3 |
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| Day 155 - Spot 1 |
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| Day 155 - Spot 2 |
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| Day 155 - Spot 3 |
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| Day 197 - Spot 1 |
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| Day 197 - Spot 2 |
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| Day 197 - Spot 3 |
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| Day 197 |
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| Day 197 |
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| Day 197 |
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| Day 197 |
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| Day 197 |
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| Day 197 |
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| After 5 STS: Day 197 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 113 |
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| After 10 STS: Day 197 |
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| After 15 STS: Day 57 |
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| After 15 STS: Day 113 |
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| After 15 STS: Day 197 |
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| After 20 STS: Day 57 |
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| After 20 STS: Day 113 |
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| After 20 STS: Day 197 |
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| After 5 STS: Day 197 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 113 |
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| After 10 STS: Day 197 |
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| After 15 STS: Day 57 |
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| After 15 STS: Day 113 |
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| After 15 STS: Day 197 |
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| After 20 STS: Day 57 |
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| After 20 STS: Day 113 |
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| After 20 STS: Day 197 |
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| After 5 STS: Day 197 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 113 |
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| After 10 STS: Day 197 |
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| After 15 STS: Day 57 |
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| After 15 STS: Day 113 |
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| After 15 STS: Day 197 |
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| After 20 STS: Day 57 |
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| After 20 STS: Day 113 |
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| After 20 STS: Day 197 |
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| After 5 STS: Day 197 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 113 |
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| After 10 STS: Day 197 |
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| After 15 STS: Day 57 |
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| After 15 STS: Day 113 |
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| After 15 STS: Day 197 |
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| After 20 STS: Day 57 |
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| After 20 STS: Day 113 |
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| After 20 STS: Day 197 |
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| After 5 STS: Day 197 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 113 |
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| After 10 STS: Day 197 |
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| After 15 STS: Day 57 |
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| After 15 STS: Day 113 |
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| After 15 STS: Day 197 |
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| After 20 STS: Day 57 |
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| After 20 STS: Day 113 |
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| After 20 STS: Day 197 |
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| After 5 STS: Day 197 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 113 |
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| After 10 STS: Day 197 |
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| After 15 STS: Day 57 |
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| After 15 STS: Day 113 |
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| After 15 STS: Day 197 |
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| After 20 STS: Day 57 |
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| After 20 STS: Day 113 |
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| After 20 STS: Day 197 |
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