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Evaluation of the Cosmetic Benefit of a Skin Cream in Healthy Females With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a Glycolic Acid Facial Peel Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103906
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Skin Care
Interventions Other: Cream (Test product)
Other: Cleanser (Reference Product)
Other: Sunscreen (Reference Product)
Enrollment 106
Recruitment Details All participants were recruited at a single center in Brazil.
Pre-assignment Details A total of 141 participants were screened, out of which 106 participants were enrolled in the study. 35 participants were not enrolled as 30 did not met study criteria, 2 had adverse event and 3 were lost to follow up. Out of 106, 82 participants were randomized and 24 were not randomized because of other reasons (unspecified).
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description Participants were instructed to apply test product (approximately 0.6-1 g[gram]) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime. Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Period Title: Overall Study
Started 40 42
Completed 36 39
Not Completed 4 3
Reason Not Completed
Adverse Event             2             3
Other             2             0
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product) Total
Hide Arm/Group Description Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime. Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days. Total of all reporting groups
Overall Number of Baseline Participants 37 40 77
Hide Baseline Analysis Population Description
Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 40 participants 77 participants
46.2  (8.41) 46.5  (8.04) 46.4  (8.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 77 participants
Female
37
 100.0%
40
 100.0%
77
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 77 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.5%
1
   1.3%
White
35
  94.6%
34
  85.0%
69
  89.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.4%
5
  12.5%
7
   9.1%
1.Primary Outcome
Title Number of Participants With Evaluator (Dermatologist) Global Assessment (EGA) Score for Well Tolerance of Product 14 Days Post-Procedure
Hide Description The Dermatologist assessed the local tolerance of the post-procedure skin care regimen in context of the expected effects of the procedure for each participant using the scale below: 0 - Product regimen was well tolerated (No clinically significant worsening of the expected signs/symptoms of the procedure. No new signs/symptoms manifest during product use) and 1 - Product regimen was not well tolerated (Clear, clinically relevant worsening of the severity or frequency of expected signs/symptoms of the procedure and/or any occurrence of new, unexpected signs/symptoms during product use). The Dermatologist drawn assessment on the total set of clinical and participant self-assessment data for each participant.
Time Frame 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population analyzed for this outcome 14 days post-procedure.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 36 39
Measure Type: Count of Participants
Unit of Measure: Participants
36
 100.0%
38
  97.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Test Product), Group 2 (No Test Product)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3334
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value 2.56
Confidence Interval (2-Sided) 95%
-19.99 to 25.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Total Score of Dermatologist Assessment Score
Hide Description Participants scored for all domains of Dermatologist Assessment Score using scale of 0 to 3. Erythema (0=None-No evidence of erythema present, 1=Mild-Slight red coloration, 2=Moderate-Definite redness, 3=Severe-Marked erythema, bright red to dusky dark red), Dryness (0=None-No dryness, 1=Mild-Barely perceptible, fine scales or flakes present to limited areas of the test site, 2=Moderate-Fine scales or flakes generalized to all areas of the test site, 3=Severe -Scaling & peeling of skin over all areas of the test site), Desquamation (0=None-No evidence of desquamation/peeling, 1=Mild-Barely perceptible scaling; evident only on scratching, 2=Moderate-Minimal scaling, adherent to the skin, 3=Severe -Moderate scaling, loosely adherent to the skin & easily removable), Edema (0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe Marked/pronounced edema present). Total score as 0 to 12, higher scores represent less local tolerance.
Time Frame At baseline (60 minutes post procedure but prior to any test product application), 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 37 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
At Baseline Number Analyzed 37 participants 40 participants
0.49  (0.651) 0.73  (0.816)
Change from baseline at 180 min. post procedure Number Analyzed 37 participants 40 participants
-0.22  (0.479) -0.25  (0.494)
Change from baseline at Day 1 post procedure Number Analyzed 37 participants 40 participants
0.24  (0.925) 0.18  (0.984)
Change from baseline at Day 2 post procedure Number Analyzed 36 participants 40 participants
0.14  (0.723) 0.23  (0.862)
Change from baseline at Day 3 post procedure Number Analyzed 36 participants 40 participants
0.11  (0.950) 0.50  (1.155)
Change from baseline at Day 7 post procedure Number Analyzed 36 participants 39 participants
-0.17  (0.655) -0.33  (0.701)
Change from baseline at Day 14 post procedure Number Analyzed 36 participants 39 participants
-0.25  (0.937) -0.51  (0.914)
3.Secondary Outcome
Title Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema
Hide Description Participants scored for all domains of Dermatologist Assessment Score using scale of 0 to 3. Erythema (0=None-No evidence of erythema present, 1=Mild-Slight red coloration, 2=Moderate-Definite redness, 3=Severe-Marked erythema, bright red to dusky dark red), Dryness (0=None-No dryness, 1=Mild-Barely perceptible, fine scales or flakes present to limited areas of the test site, 2=Moderate-Fine scales or flakes generalized to all areas of the test site, 3=Severe -Scaling & peeling of skin over all areas of the test site), Desquamation (0=None-No evidence of desquamation/peeling, 1=Mild-Barely perceptible scaling; evident only on scratching, 2=Moderate-Minimal scaling, adherent to the skin, 3=Severe -Moderate scaling, loosely adherent to the skin & easily removable), Edema (0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe Marked/pronounced edema present). Higher scores represent less local tolerance.
Time Frame At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 37 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Erythema: At Baseline Number Analyzed 37 participants 40 participants
0.32  (0.530) 0.48  (0.640)
Erythema: Change from baseline at 180 minutes Number Analyzed 37 participants 40 participants
-0.11  (0.393) -0.23  (0.480)
Erythema: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
-0.03  (0.552) -0.15  (0.700)
Erythema: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
-0.17  (0.378) -0.23  (0.620)
Erythema: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
-0.14  (0.593) -0.10  (0.744)
Erythema: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
-0.25  (0.554) -0.41  (0.595)
Erythema: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-0.19  (0.668) -0.36  (0.707)
Dryness: At Baseline Number Analyzed 37 participants 40 participants
0.14  (0.347) 0.18  (0.385)
Dryness: Change from baseline at 180 minutes Number Analyzed 37 participants 40 participants
-0.08  (0.277) 0.05  (0.316)
Dryness: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
0.16  (0.501) 0.20  (0.464)
Dryness: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
0.14  (0.593) 0.30  (0.516)
Dryness: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
0.08  (0.554) 0.33  (0.526)
Dryness: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
0.06  (0.410) 0.05  (0.456)
Dryness: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-0.06  (0.410) -0.08  (0.422)
Desquamation: At Baseline Number Analyzed 37 participants 40 participants
0.03  (0.164) 0.05  (0.221)
Desquamation: Change from baseline at 180 minutes Number Analyzed 37 participants 40 participants
-0.03  (0.164) -0.05  (0.221)
Desquamation: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
0.08  (0.433) 0.15  (0.533)
Desquamation: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
0.17  (0.507) 0.18  (0.594)
Desquamation: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
0.17  (0.507) 0.30  (0.648)
Desquamation: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
0.03  (0.291) 0.05  (0.320)
Desquamation: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
0.00  (0.239) -0.05  (0.223)
Edema: At Baseline Number Analyzed 37 participants 40 participants
0.00  (0.00) 0.03  (0.158)
Edema: Change from baseline at 180 minutes Number Analyzed 37 participants 40 participants
0.00  (0.00) -0.03  (0.158)
Edema: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
0.03  (0.164) -0.03  (0.158)
Edema: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
0.00  (0.00) -0.03  (0.158)
Edema: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
0.00  (0.00) -0.03  (0.158)
Edema: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
0.00  (0.00) -0.03  (0.160)
Edema: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
0.00  (0.00) -0.03  (0.160)
4.Secondary Outcome
Title Change From Baseline in Total Score of Participant Self-Assessment Scores
Hide Description Participant Self-Assessment was conducted by participants reflective of their skin condition at the time of evaluation. Participants scored following signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Total score ranges as 0 to 18, higher score represents less tolerance to product applied.
Time Frame At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 37 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
At Baseline Number Analyzed 37 participants 40 participants
0.70  (1.024) 1.15  (1.442)
Change from baseline at 180 minutes Number Analyzed 37 participants 40 participants
-0.43  (0.929) -0.78  (1.250)
Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
-0.24  (0.683) -0.80  (1.506)
Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
-0.36  (0.762) -0.43  (1.567)
Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
-0.50  (0.697) -0.50  (1.485)
Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
-0.67  (0.894) -0.85  (1.514)
Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-0.61  (0.994) -0.85  (1.631)
5.Secondary Outcome
Title Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness
Hide Description Participant Self-Assessment was conducted by participants reflective of their skin condition at the time of evaluation. Participants scored following signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Higher score represents less tolerance to product applied.
Time Frame At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 37 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Pain: At Baseline Number Analyzed 37 participants 40 participants
0.00  (0.00) 0.00  (0.00)
Pain: Change from baseline at 180 minutes Number Analyzed 37 participants 40 participants
0.00  (0.00) 0.00  (0.00)
Pain: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
0.00  (0.00) 0.00  (0.00)
Pain: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
0.00  (0.00) 0.00  (0.00)
Pain: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
0.00  (0.00) 0.00  (0.00)
Pain: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
0.00  (0.00) 0.00  (0.00)
Pain: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
0.00  (0.00) 0.00  (0.00)
Stinging/Burning: At Baseline Number Analyzed 37 participants 40 participants
0.24  (0.548) 0.43  (0.675)
Stinging/Burning: Change from baseline at 180 min. Number Analyzed 37 participants 40 participants
-0.19  (0.518) -0.38  (0.628)
Stinging/Burning: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
-0.22  (0.534) -0.43  (0.675)
Stinging/Burning: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
-0.25  (0.554) -0.43  (0.675)
Stinging/Burning: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
-0.25  (0.554) -0.43  (0.675)
Stinging/Burning: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
-0.25  (0.554) -0.41  (0.677)
Stinging/Burning: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-0.25  (0.554) -0.41  (0.677)
Itching: At Baseline Number Analyzed 37 participants 40 participants
0.00  (0.00) 0.10  (0.379)
Itching: Change from baseline at 180 min. Number Analyzed 37 participants 40 participants
0.00  (0.00) -0.05  (0.316)
Itching: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
0.03  (0.164) -0.05  (0.450)
Itching: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
0.03  (0.167) -0.03  (0.357)
Itching: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
0.06  (0.232) -0.05  (0.450)
Itching: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
0.00  (0.00) -0.08  (0.422)
Itching: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
0.00  (0.00) -0.10  (0.384)
Tightness: At Baseline Number Analyzed 37 participants 40 participants
0.00  (0.00) 0.08  (0.267)
Tightness: Change from baseline at 180 min. Number Analyzed 37 participants 40 participants
0.00  (0.00) -0.05  (0.221)
Tightness: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
0.05  (0.329) -0.03  (0.357)
Tightness: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
0.06  (0.232) 0.05  (0.389)
Tightness: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
0.00  (0.00) 0.05  (0.389)
Tightness: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
0.00  (0.00) -0.05  (0.223)
Tightness: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
0.00  (0.00) -0.03  (0.280)
Redness: At Baseline Number Analyzed 37 participants 40 participants
0.32  (0.530) 0.40  (0.672)
Redness: Change from baseline at 180 min. Number Analyzed 37 participants 40 participants
-0.11  (0.516) -0.20  (0.648)
Redness: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
-0.16  (0.501) -0.38  (0.667)
Redness: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
-0.33  (0.535) -0.33  (0.730)
Redness: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
-0.33  (0.535) -0.33  (0.730)
Redness: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
-0.33  (0.535) -0.38  (0.673)
Redness: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-0.33  (0.535) -0.33  (0.737)
Dryness: At Baseline Number Analyzed 37 participants 40 participants
0.14  (0.347) 0.15  (0.362)
Dryness: Change from baseline at 180 min. Number Analyzed 37 participants 40 participants
-0.14  (0.347) -0.10  (0.304)
Dryness: Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
0.05  (0.405) 0.08  (0.526)
Dryness: Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
0.14  (0.424) 0.30  (0.648)
Dryness: Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
0.03  (0.446) 0.25  (0.543)
Dryness: Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
-0.08  (0.280) 0.08  (0.580)
Dryness: Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-0.03  (0.506) 0.03  (0.486)
6.Secondary Outcome
Title Change From Baseline in Trans-epidermal Water Loss (TEWL)
Hide Description Trans-epidermal water loss (TEWL) measurement was performed by evaporimetry with a Tewameter to assess skin barrier function. Measurements was done in triplicate on the left cheek (below the cheekbone between the nose and ear). TEWL measurements was performed the participant lying horizontally, on their back, so that the chimney of the Tewameter probe was aligned vertically.
Time Frame At baseline (60 mins. post procedure but prior to any test product application) and 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants. Number of participants analyzed are the part of ITT population analyzed for this outcome at specific time points.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 37 40
Mean (Standard Deviation)
Unit of Measure: gram per square meter per hour (g/m2/hr)
At Baseline Number Analyzed 37 participants 40 participants
20.20  (5.158) 20.24  (5.242)
Change from baseline at 180 min. Number Analyzed 37 participants 40 participants
0.50  (1.940) 0.32  (1.818)
Change from baseline at 360 min. Number Analyzed 37 participants 39 participants
-0.47  (2.803) -0.72  (2.729)
Change from baseline at Day 1 Number Analyzed 36 participants 40 participants
-0.83  (2.958) -0.76  (2.567)
Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
-1.38  (2.782) -1.22  (3.182)
Change from baseline at Day 3 Number Analyzed 36 participants 40 participants
-1.27  (2.886) -0.05  (3.644)
Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
-2.39  (3.263) -0.65  (4.552)
Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-2.92  (3.028) -1.64  (4.329)
7.Secondary Outcome
Title Change From Baseline in Corneometer Measurements
Hide Description Corneometry was used to measure moisture content of stratum corneum using corneometer. The corneometer probe was placed in contact with the skin of the participant's test site for 1-2 s per measurement. The corneometer measurements were performed in triplicate at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back. Corneometer values were measured at 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure to evaluate the impact of twice-daily application of the investigational products on skin moisturization compared to the use of no test product. An increase in Corneometer values corresponds to skin-moisturizing effect.
Time Frame At baseline (60 mins. post procedure but prior to any test product application) and 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Number of participants analyzed are the part of ITT population analyzed for this outcome at specific time points.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 37 40
Mean (Standard Deviation)
Unit of Measure: corneometer units
At Baseline Number Analyzed 37 participants 40 participants
67.17  (11.017) 69.17  (11.635)
Change from baseline at 180 min. Number Analyzed 37 participants 40 participants
13.93  (9.919) -2.30  (6.388)
Change from baseline at 360 min. Number Analyzed 37 participants 40 participants
9.55  (9.915) -1.96  (7.581)
Change from baseline at Day 1 Number Analyzed 37 participants 40 participants
-2.00  (8.178) -9.75  (9.051)
Change from baseline at Day 2 Number Analyzed 36 participants 40 participants
-2.03  (9.776) -9.42  (9.349)
Change from baseline at Day 3 Number Analyzed 35 participants 40 participants
-0.36  (7.909) -6.61  (10.125)
Change from baseline at Day 7 Number Analyzed 36 participants 39 participants
-3.22  (8.232) -10.28  (10.967)
Change from baseline at Day 14 Number Analyzed 36 participants 39 participants
-0.91  (8.413) -9.18  (10.167)
8.Other Pre-specified Outcome
Title Number of Participants With Global Self-Assessment of Satisfaction Score
Hide Description Participants rated the level of satisfaction with the post-procedure skin care regimen to which they were randomized using scale as follows: 0 (Very satisfied), 1 (Satisfied), 2 (Poorly satisfied), 3 (Not at all satisfied).
Time Frame 14 days after completion of the facial peel procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description:
Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
Overall Number of Participants Analyzed 37 40
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
1
   2.7%
1
   2.5%
Very Satisfied
17
  45.9%
12
  30.0%
Satisfied
19
  51.4%
26
  65.0%
Poorly Satisfied
0
   0.0%
1
   2.5%
Not at all Satisfied
0
   0.0%
0
   0.0%
Time Frame up to 26 days (from Visit 1 to until 5 days following last administration on Visit 8)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 (Test Product) Group 2 (No Test Product)
Hide Arm/Group Description Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime. Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
All-Cause Mortality
Group 1 (Test Product) Group 2 (No Test Product)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Group 1 (Test Product) Group 2 (No Test Product)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Group 1 (Test Product) Group 2 (No Test Product)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/37 (2.70%)      2/40 (5.00%)    
Infections and infestations     
Herpes Simplex   0/37 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders     
Scab   1/37 (2.70%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin Irritation   0/37 (0.00%)  0 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03103906    
Other Study ID Numbers: 207213
First Submitted: March 24, 2017
First Posted: April 6, 2017
Results First Submitted: July 10, 2018
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019