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The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.
Two groups randomized in a ratio of [1:1] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moisturizer + Body wash | Experimental | Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day) |
|
| Body wash | Active Comparator | Cetaphil® Restoraderm® body wash (1/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash | Other |
| ||
| Cetaphil® Restoraderm® body wash |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse (Quantile 25%) | Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached. | The duration between Baseline and the first AD relapse occurred (up to 89 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology /Shenzhen Children's hospital | Shenzhen | Guangdong | 518026 | China | ||
| Hunan Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29143926 | Derived | Ma L, Li P, Tang J, Guo Y, Shen C, Chang J, Kerrouche N. Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer. Adv Ther. 2017 Dec;34(12):2601-2611. doi: 10.1007/s12325-017-0640-6. Epub 2017 Nov 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moisturizer + Body Wash | Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day) Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash |
| FG001 | Body Wash | Cetaphil® Restoraderm® body wash (1/day) Cetaphil® Restoraderm® body wash |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moisturizer + Body Wash | Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day) Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash |
| BG001 | Body Wash |
| 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 | Time to Relapse (Quantile 25%) | Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached. | Analysis was performed on intent-to-treat efficacy (ITT) population that included all participants who were enrolled and randomized. | Posted | Number | 95% Confidence Interval | Days | The duration between Baseline and the first AD relapse occurred (up to 89 days) |
|
8 months
Analysis was based on safety population that included all treated population.
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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 | Moisturizer + Body Wash | Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day) Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stéphanie Leclerc | Galderma | +33492386706 | stephanie.leclerc@galderma.com |
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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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| Other |
|
| Hunan |
| Hunan |
| 410007 |
| China |
| XinHua Hospital | Yangpu | Shanghai Municipality | 200092 | China |
| Department of Dermatology /Beijing Children's Hospital | Beijing | XI Cheng | 100045 | China |
| Philippine General Hospital | Manila | Ermita | 1000 | Philippines |
| Asian Hospital and Medical Center | Manila | Muntinlupa City | 1780 | Philippines |
| St. Luke's Medical Center | City of Taguig | Taguig City | 1634 | Philippines |
| Jose R. Reyes Memorial Medical Center | Manila | 1003 | Philippines |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Sponsor decision to withdraw subject |
|
Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Skin phototype | Skin phototype definitions according to T.B. Fitzpatrick. This was assessed by the investigator at baseline as: II: Always burns easily; tans minimally and with difficulty III:Burns minimally; tans gradually and uniformly (light brown) IV: Burns minimally; always tans well (moderate brown) | Number | participants |
|
| Atopic Dermatitis (AD) duration | Mean | Standard Deviation | years |
|
| Number of AD acute phase in the last 12 months | Mean | Standard Deviation | episodes |
|
| Duration of the last acute phase | Mean | Standard Deviation | days |
|
| Severity of the last AD acute phase | Count of Participants | Participants |
|
| Investigator's Global Assessment (IGA) | The investigator assessed the global AD severity measurement of erythema and infiltration/papules using IGA on a 6-point scale ranging from 0 = clear (no inflammatory signs of AD) ; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease (severe erythema and severe papulation/infiltration with oozing/crusting), where higher score indicated worst symptoms and decrease in score relates to an improvement in signs and symptoms. | Count of Participants | Participants |
|
| Eczema Area and Severity Index (EASI) | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. | Mean | Standard Deviation | scores on a scale |
|
Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 14 |
| 60 |
| EG001 | Body Wash | Cetaphil® Restoraderm® body wash (1/day) Cetaphil® Restoraderm® body wash | 0 | 60 | 0 | 60 | 17 | 60 |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Disclosure agreement covered by contract.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |