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The aim of this study is to evaluate the impact of twice-daily topical application of two different moisturizing creams on skin barrier function for 4 weeks.
This study will be a randomized, evaluator-blind, single-center, two-treatment regimen, controlled, parallel-group, with a treatment period of 4 weeks. The study will assess the skin barrier function of the two-treatment regimen in healthy participants with dry, sensitive skin on the face and lower legs. All participants will be centrally randomized to one of the 2 treatment groups using an Interactive Response Technology (IRT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 | Experimental | Participants will apply 2 pumps of the test product (approximately 0.3ml x 2= 0.6ml) to the randomly assigned side of the face, including forehead and chin, and 6 pumps of test product (approximately 0.3 ml x 6 = 1.8 ml) to the randomly assigned lower leg (below the knee; above the ankle) topically twice-daily (in the morning and evening) after cleansing. |
|
| Test Product 2 | Experimental | Participants will apply pea-sized amount of the test product (approximately 0.6ml) to the randomly assigned side of the face, including forehead and chin, and walnut-sized amount of the test product (approximately 1.8 ml) to the randomly assigned lower leg (below the knee; above the ankle) twice-daily (in the morning and evening) after cleansing. |
|
| Standard soap cleanser | Placebo Comparator | Participants will use wet soap with warm water and form lather. Participants will cleanse their entire face and both lower legs (between the knees and ankles) twice daily (morning and evening). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Developmental moisturizing cream 1 | Drug | Participants will topically apply developmental moisturizing cream 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value. | Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 29 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2). |
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Inclusion Criteria:
Exclusion Criteria:
18. A participant currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation 19. A participant with a recent history (within the last 5 years) of alcohol or other substance abuse.
20. A participant with any skin marks on the face or lower legs that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). 21. Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases. 22. A participant who has previously been enrolled in this study. 23. A participant who is unwilling to abstain from smoking tobacco or using any other nicotine containing products.
24. A participant with visible sunburn on any of the test sites. 25. A participant with moles, tattoos, scars, hairs, etc. at the test areas if it is likely that they could affect the assessments. 26. A participant who has used self-tanning products on the test areas (face and arms) within 2 weeks prior to the screening visit. 27. A participant who intends to expose their skin to natural or artificial ultraviolet (UV) light (e.g.
sunbathing or tanning beds). 28. A participant with any participant self-assessed or dermatologist dryness parameter score 4 (very severe) on the test areas of the lower legs or face.
29. Any participant who, in the judgment of the Investigator, should not participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Schenefeld | Schleswig-Holstein | 22869 | Germany |
A total 174 participants were screened, out of which 158 participants were enrolled, 149 participants were randomized and 25 participants not randomized. Out of 149 randomized participants, 7 participants did not completed study because 3 participants experienced adverse event, 3 participants withdrew consent and 1 participant due to other reason.
All participants were enrolled at one center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Regimen 1 (Test Product 1 + Standard Soap) | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 milliliter (mL) × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hours (hrs). |
| FG001 | Treatment Regimen 2 (Test Product 2 + Standard Soap) | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population comprised of all randomized participants who applied at least one dose of the study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Regimen 1 (Test Product 1 + Standard Soap) | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. |
| 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 | Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value. | Modified Intent-to-Treat (MITT) population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Baseline and Day 29 |
Up to Day 34
Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
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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 | Treatment Regimen 1 (Test Product 1 + Standard Soap) | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only Treatment Related Treatment Emergent Adverse Events were reported per-intervention since Treatment Emergent Adverse Events were not analysed per intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2019 | Apr 14, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 5, 2018 | Apr 16, 2020 | Prot_001.pdf |
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| Developmental moisturizing cream 2 | Drug | Participants will topically apply developmental moisturizing cream 2 |
|
| Standard cleanser soap | Other | Participants will cleanse the entire face and both lower legs (between the knees and the ankles)with simple pure soap |
|
| Baseline and Day 29 |
| Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2). | Baseline and Day 15 |
| Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2). | Baseline and Day 15 |
| Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2 | Stratum corneum (SC) moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 international units (i.u) represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered. | Baseline, 30 mins and 6 hrs after first treatment application on Day 1 and 24 hrs after treatment application on Day 2 |
| Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered. | Baseline, Day 1 and Day 2 |
| Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered. | Baseline, Day 15 and 29 |
| Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered. | Baseline, Day 15 and Day 29 |
| Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value. | Baseline, Day 30, 31, 32, 33 and 34 |
| Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value. | Baseline, Day 30, 31, 32, 33 and 34 |
| Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered. | Baseline, Day 30, 31, 32, 33 and 34 |
| Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered. | Baseline, Day 30, 31, 32, 33 and 34 |
| Change From Pre-challenge in TEWL Following Application of Test Regimen on Face (Area 3 Compared to Area 4) at 3 Different Time Points of Strips Removal (3,6 and 9) at Day 29 | Tape-stripping method was used to evaluate the impact of physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge and after 3, 6, and 9 discs had been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function. | Day 31 |
| Change From Pre-challenge in TEWL Following Application of Test Regimen on Legs (Area 7 Compared to Area 8) at 3 Different Time Points of Strips Removal (4, 8 and 12) at Day 29 | Tape-stripping method was used to evaluate the impact of a physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge after 3, 6, and 9 discs have been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function. | Pre-challenge and Day 29 |
| Total Protein Content Extracted From D-Squame Discs From a Total of 9 Adhesive Discs on Face (Area 3 Compared to Area 4) at Day 29 | Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nanometers (nm). Value displayed in percentage (%) was proportionally related to protein content. An 18 D-Squame discs were taken from participant (two sets of 9 discs from each side of the face). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 3 (right face) and area 4 (left face) on Day 29. | Day 29 |
| Total Protein Content Extracted From D-Squame Discs From a Total of 12 Adhesive Discs on Leg (Area 7 Compared to Area 8) at Day 29 | Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nm. Value displayed in percentage (%) was proportionally related to protein content. An 24 D-Squame discs were taken from participant (two sets of 12 discs from the two separate sites of each lower leg). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 7 (right leg) and area 8 (left leg) on Day 29. | Day 29 |
| Other |
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| BG001 | Treatment Regimen 2 (Test Product 2 + Standard Soap) | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants randomized to this treatment regimen and were further randomized within regimen left and right side. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Type Grading | Fitzpatrick scale was used to classify a participant's skin type by their response to sun exposure. This scale emphasizes on potentials for irritation, burns and hyperpigmentation, indicators for future product choices. This scale has six grading, where I refers to always burns easily; never tans, II refers to always burns easily; tans minimally, III refers to burns moderately; tans gradually, IV refers to burns minimally, always tans well, V refers to rarely burns, tans profusely and VI refers to never burns. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Test Product 1 | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. |
| OG001 | Test Product 2 | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. |
| OG002 | Standard Cleanser Soap | Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. |
|
|
| Secondary | Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 29 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2). | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Baseline and Day 29 |
|
|
|
| Secondary | Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2). | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Baseline and Day 15 |
|
|
|
| Secondary | Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2). | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Baseline and Day 15 |
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| Secondary | Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2 | Stratum corneum (SC) moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 international units (i.u) represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value. | Posted | Mean | Standard Deviation | International units (i.u.) | Baseline, 30 mins and 6 hrs after first treatment application on Day 1 and 24 hrs after treatment application on Day 2 |
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| Secondary | Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value. | Posted | Mean | Standard Deviation | i.u. | Baseline, Day 1 and Day 2 |
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| Secondary | Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value. | Posted | Mean | Standard Deviation | i.u. | Baseline, Day 15 and 29 |
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| Secondary | Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value. | Posted | Mean | Standard Deviation | i.u. | Baseline, Day 15 and Day 29 |
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| Secondary | Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Baseline, Day 30, 31, 32, 33 and 34 |
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| Secondary | Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 | TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Baseline, Day 30, 31, 32, 33 and 34 |
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| Secondary | Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value. | Posted | Mean | Standard Deviation | i.u. | Baseline, Day 30, 31, 32, 33 and 34 |
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| Secondary | Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 | SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value. | Posted | Mean | Standard Deviation | i.u. | Baseline, Day 30, 31, 32, 33 and 34 |
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| Secondary | Change From Pre-challenge in TEWL Following Application of Test Regimen on Face (Area 3 Compared to Area 4) at 3 Different Time Points of Strips Removal (3,6 and 9) at Day 29 | Tape-stripping method was used to evaluate the impact of physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge and after 3, 6, and 9 discs had been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Day 31 |
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| Secondary | Change From Pre-challenge in TEWL Following Application of Test Regimen on Legs (Area 7 Compared to Area 8) at 3 Different Time Points of Strips Removal (4, 8 and 12) at Day 29 | Tape-stripping method was used to evaluate the impact of a physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge after 3, 6, and 9 discs have been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function. | MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2/hr | Pre-challenge and Day 29 |
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| Secondary | Total Protein Content Extracted From D-Squame Discs From a Total of 9 Adhesive Discs on Face (Area 3 Compared to Area 4) at Day 29 | Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nanometers (nm). Value displayed in percentage (%) was proportionally related to protein content. An 18 D-Squame discs were taken from participant (two sets of 9 discs from each side of the face). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 3 (right face) and area 4 (left face) on Day 29. | MITT Population. | Posted | Mean | Standard Deviation | Percentage (%) | Day 29 |
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| Secondary | Total Protein Content Extracted From D-Squame Discs From a Total of 12 Adhesive Discs on Leg (Area 7 Compared to Area 8) at Day 29 | Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nm. Value displayed in percentage (%) was proportionally related to protein content. An 24 D-Squame discs were taken from participant (two sets of 12 discs from the two separate sites of each lower leg). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 7 (right leg) and area 8 (left leg) on Day 29. | MITT Population. | Posted | Mean | Standard Deviation | Percentage (%) | Day 29 |
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| 0 |
| 75 |
| 0 |
| 75 |
| 19 |
| 75 |
| EG001 | Treatment Regimen 2 (Test Product 2 + Standard Soap) | Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. | 0 | 74 | 0 | 74 | 23 | 74 |
| EG002 | Test Product 1 | Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs | 0 | 75 | 0 | 75 | 5 | 75 |
| EG003 | Test Product 2 | Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. | 0 | 74 | 0 | 74 | 4 | 74 |
| EG004 | Standard Soap | Participants applied standard cleanser soap (for cleansing purpose) topically before applying allocated either Test Product 1 or Test Product 2 to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs. | 0 | 149 | 0 | 149 | 7 | 149 |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only Treatment Related Treatment Emergent Adverse Events were reported per-intervention since Treatment Emergent Adverse Events were not analysed per intervention. |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only Treatment Related Treatment Emergent Adverse Events were reported per-intervention since Treatment Emergent Adverse Events were not analysed per intervention. |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only Treatment Related Treatment Emergent Adverse Events were reported per-intervention since Treatment Emergent Adverse Events were not analysed per intervention. |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only Treatment Related Treatment Emergent Adverse Events were reported per-intervention since Treatment Emergent Adverse Events were not analysed per intervention. |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only Treatment Related Treatment Emergent Adverse Events were reported per-intervention since Treatment Emergent Adverse Events were not analysed per intervention. |
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| Nasopharyngitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Oral herpes | Infections and infestations | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Conjunctivitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Rash pustular | Infections and infestations | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only Treatment Related Treatment Emergent Adverse Events were reported per-intervention since Treatment Emergent Adverse Events were not analysed per intervention. |
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| Sinusitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Headache | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Contusion | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Toothache | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Haematoma | Vascular disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Blepharitis | Eye disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Conjunctivitis allergic | Eye disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment | All Treatment Emergent Adverse Events were reported by treatment regimen and only were not analyzed per intervention. |
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GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Day 1, 6 hrs |
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| Day 2, Visit 3 |
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| Day 1, 6 hrs |
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| Day 2, Visit 3 |
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| Day 29, Visit 5 |
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| Day 29, Visit 5 |
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| Day 31, Visit 7 |
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| Day 32, Visit 8 |
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| Day 33, Visit 9 |
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| Day 34, Visit 10 |
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| Day 31, Visit 7 |
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| Day 32, Visit 8 |
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| Day 33, Visit 9 |
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| Day 34, Visit 10 |
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| Day 31, Visit 7 |
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| Day 32, Change at visit 8 |
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| Day 33, Visit 9 |
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| Day 34, Visit 10 |
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| Day 31, Visit 7 |
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| Day 32, Visit 8 |
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| Day 33, Visit 9 |
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| Day 34, Visit 10 |
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| Removal of 6 tape strips |
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| Removal of 9 tape strips |
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| Removal of 8 tape strips |
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| Removal of 12 tape strips |
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