Trial Outcomes & Findings for 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 (NCT NCT03103906)

Last Updated: 2019-02-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

106 participants

Primary outcome timeframe

14 days after completion of the facial peel procedure

Results posted on

2019-02-20

Participant Flow

All participants were recruited at a single center in Brazil.

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).

Participant milestones

Participant milestones
Measure	Group 1 (Test Product) 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.	Group 2 (No Test Product) 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 Study STARTED	40	42
Overall Study COMPLETED	36	39
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (Test Product) 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.	Group 2 (No Test Product) 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 Study Adverse Event	2	3
Overall Study Other	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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 n=77 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 8.41 • n=5 Participants	46.5 years STANDARD_DEVIATION 8.04 • n=7 Participants	46.4 years STANDARD_DEVIATION 8.16 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: 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.

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=36 Participants 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.	Group 2 (No Test Product) n=39 Participants 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.
Number of Participants With Evaluator (Dermatologist) Global Assessment (EGA) Score for Well Tolerance of Product 14 Days Post-Procedure	36 Participants	38 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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.
Change From Baseline in Total Score of Dermatologist Assessment Score At Baseline	0.49 score on a scale Standard Deviation 0.651	0.73 score on a scale Standard Deviation 0.816
Change From Baseline in Total Score of Dermatologist Assessment Score Change from baseline at 180 min. post procedure	-0.22 score on a scale Standard Deviation 0.479	-0.25 score on a scale Standard Deviation 0.494
Change From Baseline in Total Score of Dermatologist Assessment Score Change from baseline at Day 1 post procedure	0.24 score on a scale Standard Deviation 0.925	0.18 score on a scale Standard Deviation 0.984
Change From Baseline in Total Score of Dermatologist Assessment Score Change from baseline at Day 2 post procedure	0.14 score on a scale Standard Deviation 0.723	0.23 score on a scale Standard Deviation 0.862
Change From Baseline in Total Score of Dermatologist Assessment Score Change from baseline at Day 3 post procedure	0.11 score on a scale Standard Deviation 0.950	0.50 score on a scale Standard Deviation 1.155
Change From Baseline in Total Score of Dermatologist Assessment Score Change from baseline at Day 7 post procedure	-0.17 score on a scale Standard Deviation 0.655	-0.33 score on a scale Standard Deviation 0.701
Change From Baseline in Total Score of Dermatologist Assessment Score Change from baseline at Day 14 post procedure	-0.25 score on a scale Standard Deviation 0.937	-0.51 score on a scale Standard Deviation 0.914

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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.
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Erythema: At Baseline	0.32 score on a scale Standard Deviation 0.530	0.48 score on a scale Standard Deviation 0.640
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Erythema: Change from baseline at 180 minutes	-0.11 score on a scale Standard Deviation 0.393	-0.23 score on a scale Standard Deviation 0.480
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Erythema: Change from baseline at Day 1	-0.03 score on a scale Standard Deviation 0.552	-0.15 score on a scale Standard Deviation 0.700
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Erythema: Change from baseline at Day 2	-0.17 score on a scale Standard Deviation 0.378	-0.23 score on a scale Standard Deviation 0.620
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Erythema: Change from baseline at Day 3	-0.14 score on a scale Standard Deviation 0.593	-0.10 score on a scale Standard Deviation 0.744
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Erythema: Change from baseline at Day 7	-0.25 score on a scale Standard Deviation 0.554	-0.41 score on a scale Standard Deviation 0.595
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Erythema: Change from baseline at Day 14	-0.19 score on a scale Standard Deviation 0.668	-0.36 score on a scale Standard Deviation 0.707
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Dryness: At Baseline	0.14 score on a scale Standard Deviation 0.347	0.18 score on a scale Standard Deviation 0.385
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Dryness: Change from baseline at 180 minutes	-0.08 score on a scale Standard Deviation 0.277	0.05 score on a scale Standard Deviation 0.316
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Dryness: Change from baseline at Day 1	0.16 score on a scale Standard Deviation 0.501	0.20 score on a scale Standard Deviation 0.464
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Dryness: Change from baseline at Day 2	0.14 score on a scale Standard Deviation 0.593	0.30 score on a scale Standard Deviation 0.516
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Dryness: Change from baseline at Day 3	0.08 score on a scale Standard Deviation 0.554	0.33 score on a scale Standard Deviation 0.526
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Dryness: Change from baseline at Day 7	0.06 score on a scale Standard Deviation 0.410	0.05 score on a scale Standard Deviation 0.456
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Dryness: Change from baseline at Day 14	-0.06 score on a scale Standard Deviation 0.410	-0.08 score on a scale Standard Deviation 0.422
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Desquamation: At Baseline	0.03 score on a scale Standard Deviation 0.164	0.05 score on a scale Standard Deviation 0.221
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Desquamation: Change from baseline at 180 minutes	-0.03 score on a scale Standard Deviation 0.164	-0.05 score on a scale Standard Deviation 0.221
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Desquamation: Change from baseline at Day 1	0.08 score on a scale Standard Deviation 0.433	0.15 score on a scale Standard Deviation 0.533
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Desquamation: Change from baseline at Day 2	0.17 score on a scale Standard Deviation 0.507	0.18 score on a scale Standard Deviation 0.594
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Desquamation: Change from baseline at Day 3	0.17 score on a scale Standard Deviation 0.507	0.30 score on a scale Standard Deviation 0.648
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Desquamation: Change from baseline at Day 7	0.03 score on a scale Standard Deviation 0.291	0.05 score on a scale Standard Deviation 0.320
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Desquamation: Change from baseline at Day 14	0.00 score on a scale Standard Deviation 0.239	-0.05 score on a scale Standard Deviation 0.223
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Edema: At Baseline	0.00 score on a scale Standard Deviation 0.00	0.03 score on a scale Standard Deviation 0.158
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Edema: Change from baseline at 180 minutes	0.00 score on a scale Standard Deviation 0.00	-0.03 score on a scale Standard Deviation 0.158
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Edema: Change from baseline at Day 1	0.03 score on a scale Standard Deviation 0.164	-0.03 score on a scale Standard Deviation 0.158
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Edema: Change from baseline at Day 2	0.00 score on a scale Standard Deviation 0.00	-0.03 score on a scale Standard Deviation 0.158
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Edema: Change from baseline at Day 3	0.00 score on a scale Standard Deviation 0.00	-0.03 score on a scale Standard Deviation 0.158
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Edema: Change from baseline at Day 7	0.00 score on a scale Standard Deviation 0.00	-0.03 score on a scale Standard Deviation 0.160
Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema Edema: Change from baseline at Day 14	0.00 score on a scale Standard Deviation 0.00	-0.03 score on a scale Standard Deviation 0.160

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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.
Change From Baseline in Total Score of Participant Self-Assessment Scores At Baseline	0.70 score on a scale Standard Deviation 1.024	1.15 score on a scale Standard Deviation 1.442
Change From Baseline in Total Score of Participant Self-Assessment Scores Change from baseline at 180 minutes	-0.43 score on a scale Standard Deviation 0.929	-0.78 score on a scale Standard Deviation 1.250
Change From Baseline in Total Score of Participant Self-Assessment Scores Change from baseline at Day 1	-0.24 score on a scale Standard Deviation 0.683	-0.80 score on a scale Standard Deviation 1.506
Change From Baseline in Total Score of Participant Self-Assessment Scores Change from baseline at Day 2	-0.36 score on a scale Standard Deviation 0.762	-0.43 score on a scale Standard Deviation 1.567
Change From Baseline in Total Score of Participant Self-Assessment Scores Change from baseline at Day 3	-0.50 score on a scale Standard Deviation 0.697	-0.50 score on a scale Standard Deviation 1.485
Change From Baseline in Total Score of Participant Self-Assessment Scores Change from baseline at Day 7	-0.67 score on a scale Standard Deviation 0.894	-0.85 score on a scale Standard Deviation 1.514
Change From Baseline in Total Score of Participant Self-Assessment Scores Change from baseline at Day 14	-0.61 score on a scale Standard Deviation 0.994	-0.85 score on a scale Standard Deviation 1.631

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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.
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Pain: At Baseline	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Pain: Change from baseline at 180 minutes	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Pain: Change from baseline at Day 1	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Pain: Change from baseline at Day 2	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Pain: Change from baseline at Day 3	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Pain: Change from baseline at Day 7	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Pain: Change from baseline at Day 14	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Stinging/Burning: At Baseline	0.24 score on a scale Standard Deviation 0.548	0.43 score on a scale Standard Deviation 0.675
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Stinging/Burning: Change from baseline at 180 min.	-0.19 score on a scale Standard Deviation 0.518	-0.38 score on a scale Standard Deviation 0.628
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Stinging/Burning: Change from baseline at Day 1	-0.22 score on a scale Standard Deviation 0.534	-0.43 score on a scale Standard Deviation 0.675
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Stinging/Burning: Change from baseline at Day 2	-0.25 score on a scale Standard Deviation 0.554	-0.43 score on a scale Standard Deviation 0.675
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Stinging/Burning: Change from baseline at Day 3	-0.25 score on a scale Standard Deviation 0.554	-0.43 score on a scale Standard Deviation 0.675
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Stinging/Burning: Change from baseline at Day 7	-0.25 score on a scale Standard Deviation 0.554	-0.41 score on a scale Standard Deviation 0.677
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Stinging/Burning: Change from baseline at Day 14	-0.25 score on a scale Standard Deviation 0.554	-0.41 score on a scale Standard Deviation 0.677
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Itching: At Baseline	0.00 score on a scale Standard Deviation 0.00	0.10 score on a scale Standard Deviation 0.379
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Itching: Change from baseline at 180 min.	0.00 score on a scale Standard Deviation 0.00	-0.05 score on a scale Standard Deviation 0.316
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Itching: Change from baseline at Day 1	0.03 score on a scale Standard Deviation 0.164	-0.05 score on a scale Standard Deviation 0.450
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Itching: Change from baseline at Day 2	0.03 score on a scale Standard Deviation 0.167	-0.03 score on a scale Standard Deviation 0.357
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Itching: Change from baseline at Day 3	0.06 score on a scale Standard Deviation 0.232	-0.05 score on a scale Standard Deviation 0.450
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Itching: Change from baseline at Day 7	0.00 score on a scale Standard Deviation 0.00	-0.08 score on a scale Standard Deviation 0.422
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Itching: Change from baseline at Day 14	0.00 score on a scale Standard Deviation 0.00	-0.10 score on a scale Standard Deviation 0.384
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Tightness: At Baseline	0.00 score on a scale Standard Deviation 0.00	0.08 score on a scale Standard Deviation 0.267
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Tightness: Change from baseline at 180 min.	0.00 score on a scale Standard Deviation 0.00	-0.05 score on a scale Standard Deviation 0.221
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Tightness: Change from baseline at Day 1	0.05 score on a scale Standard Deviation 0.329	-0.03 score on a scale Standard Deviation 0.357
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Tightness: Change from baseline at Day 2	0.06 score on a scale Standard Deviation 0.232	0.05 score on a scale Standard Deviation 0.389
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Tightness: Change from baseline at Day 3	0.00 score on a scale Standard Deviation 0.00	0.05 score on a scale Standard Deviation 0.389
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Tightness: Change from baseline at Day 7	0.00 score on a scale Standard Deviation 0.00	-0.05 score on a scale Standard Deviation 0.223
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Tightness: Change from baseline at Day 14	0.00 score on a scale Standard Deviation 0.00	-0.03 score on a scale Standard Deviation 0.280
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Redness: At Baseline	0.32 score on a scale Standard Deviation 0.530	0.40 score on a scale Standard Deviation 0.672
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Redness: Change from baseline at 180 min.	-0.11 score on a scale Standard Deviation 0.516	-0.20 score on a scale Standard Deviation 0.648
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Redness: Change from baseline at Day 1	-0.16 score on a scale Standard Deviation 0.501	-0.38 score on a scale Standard Deviation 0.667
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Redness: Change from baseline at Day 2	-0.33 score on a scale Standard Deviation 0.535	-0.33 score on a scale Standard Deviation 0.730
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Redness: Change from baseline at Day 3	-0.33 score on a scale Standard Deviation 0.535	-0.33 score on a scale Standard Deviation 0.730
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Redness: Change from baseline at Day 7	-0.33 score on a scale Standard Deviation 0.535	-0.38 score on a scale Standard Deviation 0.673
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Redness: Change from baseline at Day 14	-0.33 score on a scale Standard Deviation 0.535	-0.33 score on a scale Standard Deviation 0.737
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Dryness: At Baseline	0.14 score on a scale Standard Deviation 0.347	0.15 score on a scale Standard Deviation 0.362
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Dryness: Change from baseline at 180 min.	-0.14 score on a scale Standard Deviation 0.347	-0.10 score on a scale Standard Deviation 0.304
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Dryness: Change from baseline at Day 1	0.05 score on a scale Standard Deviation 0.405	0.08 score on a scale Standard Deviation 0.526
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Dryness: Change from baseline at Day 2	0.14 score on a scale Standard Deviation 0.424	0.30 score on a scale Standard Deviation 0.648
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Dryness: Change from baseline at Day 3	0.03 score on a scale Standard Deviation 0.446	0.25 score on a scale Standard Deviation 0.543
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Dryness: Change from baseline at Day 7	-0.08 score on a scale Standard Deviation 0.280	0.08 score on a scale Standard Deviation 0.580
Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness Dryness: Change from baseline at Day 14	-0.03 score on a scale Standard Deviation 0.506	0.03 score on a scale Standard Deviation 0.486

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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.
Change From Baseline in Trans-epidermal Water Loss (TEWL) Change from baseline at Day 1	-0.83 gram per square meter per hour (g/m2/hr) Standard Deviation 2.958	-0.76 gram per square meter per hour (g/m2/hr) Standard Deviation 2.567
Change From Baseline in Trans-epidermal Water Loss (TEWL) At Baseline	20.20 gram per square meter per hour (g/m2/hr) Standard Deviation 5.158	20.24 gram per square meter per hour (g/m2/hr) Standard Deviation 5.242
Change From Baseline in Trans-epidermal Water Loss (TEWL) Change from baseline at 180 min.	0.50 gram per square meter per hour (g/m2/hr) Standard Deviation 1.940	0.32 gram per square meter per hour (g/m2/hr) Standard Deviation 1.818
Change From Baseline in Trans-epidermal Water Loss (TEWL) Change from baseline at 360 min.	-0.47 gram per square meter per hour (g/m2/hr) Standard Deviation 2.803	-0.72 gram per square meter per hour (g/m2/hr) Standard Deviation 2.729
Change From Baseline in Trans-epidermal Water Loss (TEWL) Change from baseline at Day 2	-1.38 gram per square meter per hour (g/m2/hr) Standard Deviation 2.782	-1.22 gram per square meter per hour (g/m2/hr) Standard Deviation 3.182
Change From Baseline in Trans-epidermal Water Loss (TEWL) Change from baseline at Day 3	-1.27 gram per square meter per hour (g/m2/hr) Standard Deviation 2.886	-0.05 gram per square meter per hour (g/m2/hr) Standard Deviation 3.644
Change From Baseline in Trans-epidermal Water Loss (TEWL) Change from baseline at Day 7	-2.39 gram per square meter per hour (g/m2/hr) Standard Deviation 3.263	-0.65 gram per square meter per hour (g/m2/hr) Standard Deviation 4.552
Change From Baseline in Trans-epidermal Water Loss (TEWL) Change from baseline at Day 14	-2.92 gram per square meter per hour (g/m2/hr) Standard Deviation 3.028	-1.64 gram per square meter per hour (g/m2/hr) Standard Deviation 4.329

SECONDARY outcome

Population: ITT population included all randomized participants. Number of participants analyzed are the part of ITT population analyzed for this outcome at specific time points.

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.

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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.
Change From Baseline in Corneometer Measurements At Baseline	67.17 corneometer units Standard Deviation 11.017	69.17 corneometer units Standard Deviation 11.635
Change From Baseline in Corneometer Measurements Change from baseline at 180 min.	13.93 corneometer units Standard Deviation 9.919	-2.30 corneometer units Standard Deviation 6.388
Change From Baseline in Corneometer Measurements Change from baseline at 360 min.	9.55 corneometer units Standard Deviation 9.915	-1.96 corneometer units Standard Deviation 7.581
Change From Baseline in Corneometer Measurements Change from baseline at Day 1	-2.00 corneometer units Standard Deviation 8.178	-9.75 corneometer units Standard Deviation 9.051
Change From Baseline in Corneometer Measurements Change from baseline at Day 2	-2.03 corneometer units Standard Deviation 9.776	-9.42 corneometer units Standard Deviation 9.349
Change From Baseline in Corneometer Measurements Change from baseline at Day 3	-0.36 corneometer units Standard Deviation 7.909	-6.61 corneometer units Standard Deviation 10.125
Change From Baseline in Corneometer Measurements Change from baseline at Day 7	-3.22 corneometer units Standard Deviation 8.232	-10.28 corneometer units Standard Deviation 10.967
Change From Baseline in Corneometer Measurements Change from baseline at Day 14	-0.91 corneometer units Standard Deviation 8.413	-9.18 corneometer units Standard Deviation 10.167

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: ITT population included all randomized participants.

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).

Outcome measures

Outcome measures
Measure	Group 1 (Test Product) n=37 Participants 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.	Group 2 (No Test Product) n=40 Participants 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.
Number of Participants With Global Self-Assessment of Satisfaction Score Missing	1 Participants	1 Participants
Number of Participants With Global Self-Assessment of Satisfaction Score Very Satisfied	17 Participants	12 Participants
Number of Participants With Global Self-Assessment of Satisfaction Score Satisfied	19 Participants	26 Participants
Number of Participants With Global Self-Assessment of Satisfaction Score Poorly Satisfied	0 Participants	1 Participants
Number of Participants With Global Self-Assessment of Satisfaction Score Not at all Satisfied	0 Participants	0 Participants

Adverse Events

Group 1 (Test Product)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2 (No Test Product)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 (Test Product) n=37 participants at risk 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.	Group 2 (No Test Product) n=40 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Scab	2.7% 1/37 • Number of events 1 • up to 26 days (from Visit 1 to until 5 days following last administration on Visit 8)	0.00% 0/40 • up to 26 days (from Visit 1 to until 5 days following last administration on Visit 8)
Skin and subcutaneous tissue disorders Skin Irritation	0.00% 0/37 • up to 26 days (from Visit 1 to until 5 days following last administration on Visit 8)	2.5% 1/40 • Number of events 1 • up to 26 days (from Visit 1 to until 5 days following last administration on Visit 8)
Infections and infestations Herpes Simplex	0.00% 0/37 • up to 26 days (from Visit 1 to until 5 days following last administration on Visit 8)	2.5% 1/40 • Number of events 1 • up to 26 days (from Visit 1 to until 5 days following last administration on Visit 8)

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER