Trial Outcomes & Findings for Assessment 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 NCT03197883)

NCT ID: NCT03197883

Last Updated: 2019-07-31

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 as below: 0 - Product regimen was well tolerated, 1 - product regimen was not well tolerated. The dermatologist observed on the total set of clinical and participant self-assessment data for each participant. Lower scale value implies that no clinically significant worsening of the expected signs/symptoms of the procedure, no new signs/symptoms manifest during product use. Whereas, higher scale value implies 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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 123 participants
• Primary outcome timeframe: 14 days after completion of the facial peel procedure
• Results posted on: 2019-07-31

Participant Flow

All the participants were recruited from one center in Brazil.

A total of 163 participants were screened, out of which 31 did not meet study criteria, 7 had adverse events (AEs), 1 participant was lost to follow-up, 1 withdrew his consent and 23 participants were not randomized in the study due to other reasons (not specified).

Participant milestones

Measure	Test Product Participants applied a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Overall Study STARTED	50	50
Overall Study COMPLETED	47	44
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	Test Product Participants applied a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	0
Overall Study Other (Not Specified)	0	5

Baseline Characteristics

Assessment 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

Measure	Test Product n=50 Participants Participants dispensed a pea-sized quantity of test product (approximately 0.6-1 g) onto the fingertips and applied twice daily (morning and evening) to the full face after cleansing. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen; approximately 0.6 to 1.0 g) on the full face in the morning (after application of test product) and at lunchtime.	No Treatment n=46 Participants Participants dispensed approximately 0.6 to 1.0 g of cleanser into the hands, worked into a lather, massaged onto the full face (wet skin), and rinsed with water, twice a day (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.	Total n=96 Participants Total of all reporting groups
Age, Continuous	45.9 Years STANDARD_DEVIATION 7.54 • n=5 Participants	45.1 Years STANDARD_DEVIATION 8.35 • n=7 Participants	45.5 Years STANDARD_DEVIATION 7.90 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	46 Participants n=7 Participants	96 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	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	36 Participants n=7 Participants	81 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	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Fitzpatrick Skin Type I- Always Burns, Never Tans	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick Skin Type II- Usually Burns, Tans Minimally	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Fitzpatrick Skin Type III- Sometimes mild Burn, Tans uniformly	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Fitzpatrick Skin Type IV- Burns Minimally, Always Tans well	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick Skin Type V- Very rarely Burns, Tans very easily	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick Skin Type VI- Never Burns, Never Tans	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

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 as below: 0 - Product regimen was well tolerated, 1 - product regimen was not well tolerated. The dermatologist observed on the total set of clinical and participant self-assessment data for each participant. Lower scale value implies that no clinically significant worsening of the expected signs/symptoms of the procedure, no new signs/symptoms manifest during product use. Whereas, higher scale value implies 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.

Outcome measures

Measure	Test Product n=47 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=44 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores Product was well tolerated	47 Participants	44 Participants
Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores Product was not well tolerated	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The assessments of Erythema, Dryness, Desquamation and Edema were conducted by a dermatologist on the participant's skin condition at the 5 x 5 cm square area on the volar surface of forearm. The signs were scored on a scale. Erythema on 0-3 where, 0=none-no redness, 1=mild-slight redness, 2=moderate-definite redness, 3=severe-marked redness. Dryness on 0-3 where, 0=none-no dryness, 1=mild-barely perceptible, fine scales to limited areas of test site, 2=moderate-fine scales generalized to all areas of test site, 3=severe-scaling and peeling of skin over all areas of test site. Desquamation on 0-3 where, 0=none-no sign of peeling, 1=mild-barely perceptible scaling, 2=moderate-minimal scaling, 3=severe-moderate scaling. Edema on 0-3 where, 0=none-no edema, 1=mild-barely perceptible edema, 2=moderate-definite edema, 3=severe-pronounced edema. The measure is sum of participant scores, so a total score scale ranges from 0-12, with higher scores indicating increased signs of irritation.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Total Score of Dermatologist Assessments At Baseline	1.14 Score on Scale Standard Deviation 0.904	1.00 Score on Scale Standard Deviation 0.730
Change From Baseline in Total Score of Dermatologist Assessments 14 days after completion	0.06 Score on Scale Standard Deviation 0.438	0.09 Score on Scale Standard Deviation 0.362
Change From Baseline in Total Score of Dermatologist Assessments Change from Baseline at 14 days after completion	-1.11 Score on Scale Standard Deviation 0.814	-0.86 Score on Scale Standard Deviation 0.824

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The signs/symptoms of participants were scored on a scale of 0 to 3 as below: Erythema: Score from 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 in color. Dryness: Score from 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 and peeling of skin over all areas of the test site. Desquamation score from 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 and easily removable. Edema score from 0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe-Marked/pronounced edema present.

Outcome measures

Measure	Test Product n=47 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=44 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Erythema at 14 days after completion · Mild	1 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Erythema at 14 days after completion · Moderate	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Erythema at 14 days after completion · Severe	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Dryness at 14 days after completion · None	46 Participants	41 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Dryness at 14 days after completion · Mild	1 Participants	3 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Dryness at 14 days after completion · Moderate	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Dryness at 14 days after completion · Severe	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Desquamation at 14 days after completion · None	46 Participants	43 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Desquamation at 14 days after completion · Mild	1 Participants	1 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Desquamation at 14 days after completion · Moderate	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Desquamation at 14 days after completion · Severe	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Edema at 14 days after completion · None	47 Participants	44 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Edema at 14 days after completion · Mild	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Edema at 14 days after completion · Moderate	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Edema at 14 days after completion · Severe	0 Participants	0 Participants
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness Erythema at 14 days after completion · None	46 Participants	44 Participants

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The assessments of Pain, Stinging/ Burning, Itching, Tightness, Redness and Dryness were conducted by participants reflective of their skin condition at the 5 x 5 cm square area on the volar surface of the forearm at the time of evaluation. Participants were scored as per signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3, where 0= none; no sign or symptoms, 1= mild; barely perceptible, 2= moderate; definite signs and symptoms, and 3= severe- marked or pronounced signs or symptoms. This outcome measure is the sum of participant scores, so a total score, i.e. the range is 0-15, with higher scores indicating increased signs or symptoms of irritation.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Sum of Participant Self-assessment Scores for Redness, Pain, Stinging/Burning, Itching, Tightness and Dryness At Baseline	0.38 Score on Scale Standard Deviation 0.635	0.41 Score on Scale Standard Deviation 0.805
Change From Baseline in Sum of Participant Self-assessment Scores for Redness, Pain, Stinging/Burning, Itching, Tightness and Dryness 14 days after completion	0.02 Score on Scale Standard Deviation 0.146	0.05 Score on Scale Standard Deviation 0.211
Change From Baseline in Sum of Participant Self-assessment Scores for Redness, Pain, Stinging/Burning, Itching, Tightness and Dryness Change from Baseline at 14 day after completion	-0.38 Score on Scale Standard Deviation 0.677	-0.39 Score on Scale Standard Deviation 0.841

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for redness. Participants were score on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Participant Self-assessment Scores for Redness At Baseline	0.22 Score on Scale Standard Deviation 0.507	0.15 Score on Scale Standard Deviation 0.420
Change From Baseline in Participant Self-assessment Scores for Redness 14 days after completion	0.0 Score on Scale Standard Deviation 0.00	0.0 Score on Scale Standard Deviation 0.00
Change From Baseline in Participant Self-assessment Scores for Redness Change from Baseline at 14 days after completion	-0.23 Score on Scale Standard Deviation 0.520	-0.16 Score on Scale Standard Deviation 0.428

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for pain. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Participant Self-assessment Scores for Pain At Baseline	0.0 Score on Scale Standard Deviation 0.00	0.0 Score on Scale Standard Deviation 0.00
Change From Baseline in Participant Self-assessment Scores for Pain 14 days after completion	0.0 Score on Scale Standard Deviation 0.00	00 Score on Scale Standard Deviation 0.00
Change From Baseline in Participant Self-assessment Scores for Pain Change from Baseline at 14 days after completion	0.0 Score on Scale Standard Deviation 0.00	0.0 Score on Scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for itching. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Participant Self-assessment Scores for Itching At Baseline	0.04 Score on Scale Standard Deviation 0.198	0.02 Score on Scale Standard Deviation 0.147
Change From Baseline in Participant Self-assessment Scores for Itching 14 days after completion	0.0 Score on Scale Standard Deviation 0.00	0.02 Score on Scale Standard Deviation 0.151
Change From Baseline in Participant Self-assessment Scores for Itching Change from Baseline at 14 days after completion	-0.04 Score on Scale Standard Deviation 0.204	0.0 Score on Scale Standard Deviation 0.216

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for stinging/burning. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Participant Self-assessment Scores for Stinging/Burning At Baseline	0.10 Score on Scale Standard Deviation 0.303	0.20 Score on Scale Standard Deviation 0.453
Change From Baseline in Participant Self-assessment Scores for Stinging/Burning 14 days after completion	0.0 Score on Scale Standard Deviation 0.00	0.0 Score on Scale Standard Deviation 0.00
Change From Baseline in Participant Self-assessment Scores for Stinging/Burning Change from Baseline at 14 days after completion	-0.11 Score on Scale Standard Deviation 0.312	-0.20 Score on Scale Standard Deviation 0.462

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for tightness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Participant Self-assessment Scores for Tightness At Baseline	0.0 Score on Scale Standard Deviation 0.00	0.0 Score on Scale Standard Deviation 0.00
Change From Baseline in Participant Self-assessment Scores for Tightness 14 days after completion	0.0 Score on Scale Standard Deviation 0.00	0.0 Score on Scale Standard Deviation 0.00
Change From Baseline in Participant Self-assessment Scores for Tightness Change from Baseline at 14 days after completion	0.0 Score on Scale Standard Deviation 0.00	0.0 Score on Scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.

The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for dryness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Participant Self-assessment Scores for Dryness At Baseline	0.02 Score on Scale Standard Deviation 0.141	0.04 Score on Scale Standard Deviation 0.206
Change From Baseline in Participant Self-assessment Scores for Dryness 14 days after completion	0.02 Score on Scale Standard Deviation 0.146	0.02 Score on Scale Standard Deviation 0.151
Change From Baseline in Participant Self-assessment Scores for Dryness Change from Baseline at 14 days after completion	0.0 Score on Scale Standard Deviation 0.209	-0.02 Score on Scale Standard Deviation 0.263

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: Analysis of TEWL was performed on Intent-to-Treat (ITT) population(N=96). Population was based on treatment to which participant was randomized. Of which, there were 50 in test product and 46 in no treatment. Here, number of participants (n=91) analyzed signifies those who were evaluated.

Trans-epidermal water loss (TEWL) measurement was performed by evaporimetry with a Tewameter. Measurements were taken in triplicates on the left cheek (below the cheekbone between the nose and ear). TEWL measurements were taken with the participant lying horizontally, on their back, so that the chimney of the Tewameter probe is aligned vertically. An increase in TEWL values shows damage to the skin barrier function.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Instrumental Measurement of Barrier Function Using Tewameter At Baseline	20.22 g/m^2/hr Standard Deviation 6.181	18.16 g/m^2/hr Standard Deviation 4.832
Change From Baseline in Instrumental Measurement of Barrier Function Using Tewameter 14 days after completion	17.06 g/m^2/hr Standard Deviation 3.937	16.29 g/m^2/hr Standard Deviation 3.444
Change From Baseline in Instrumental Measurement of Barrier Function Using Tewameter Change from Baseline at 14 days after completion	-3.37 g/m^2/hr Standard Deviation 4.181	-1.52 g/m^2/hr Standard Deviation 3.571

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: Analysis of Corneometry was measured on Intent to Treat (ITT) population (N=96). Population was based on treatment to which participant was randomized. Of which, there were 50 in test product and 46 in no treatment. Here, number of participants (n=91) analyzed signifies those who were evaluated.

Measurement of stratum corneum hydration was performed by the electrical capacitance method with a Corneometer. Corneometer measurements were taken in triplicates at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.

Outcome measures

Measure	Test Product n=50 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=46 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Change From Baseline in Instrumental Measurement of Moisturisation Using Corneometer At Baseline	71.39 Corneometer Units Standard Deviation 8.919	75.31 Corneometer Units Standard Deviation 9.718
Change From Baseline in Instrumental Measurement of Moisturisation Using Corneometer 14 days after completion	67.09 Corneometer Units Standard Deviation 7.535	65.47 Corneometer Units Standard Deviation 9.279
Change From Baseline in Instrumental Measurement of Moisturisation Using Corneometer Change from Baseline at 14 days after completion	-4.03 Corneometer Units Standard Deviation 7.298	-10.33 Corneometer Units Standard Deviation 10.094

SECONDARY outcome

Timeframe: 14 days after completion of the facial peel procedure

Population: Global self-assessment of satisfaction was measured on ITT population (N=91). Population was based on treatment to which participant was randomized. Of which, there were 50 in test product and 46 in no treatment. Here, number of participants (n=91) analyzed signifies those who were evaluated.

Participants has rated the level of satisfaction with the post-procedure skin care regimen to which they were randomized on a scale of 0 to 3 as follows: 0 (Very satisfied), 1 (Satisfied), 2 (Poorly satisfied), 3 (Not at all satisfied). Lower scores indicate better results.

Outcome measures

Measure	Test Product n=47 Participants Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. 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.	No Treatment n=44 Participants Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Global Self-assessment of Participants Very Satisfied	21 Participants	17 Participants
Global Self-assessment of Participants Satisfied	26 Participants	27 Participants
Global Self-assessment of Participants Poorly Satisfied	0 Participants	0 Participants
Global Self-assessment of Participants Not at all Satisfied	0 Participants	0 Participants

Adverse Events

Test Product

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Product n=50 participants at risk Participants will apply a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips and will apply twice daily (morning and evening) to the full face after cleansing. All participants will be 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.	No Treatment n=46 participants at risk Participants will wet face with water and work a small amount of facial cleanser (approximately 0.6-1 g) into lather. Massage topically onto wet skin and rinse with water twice daily (morning and evening). After cleansing, participants will apply a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
Gastrointestinal disorders Diarrhoea	2.0% 1/50 • Number of events 1 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.	0.00% 0/46 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.
Gastrointestinal disorders Lip Dry	2.0% 1/50 • Number of events 1 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.	0.00% 0/46 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.
Skin and subcutaneous tissue disorders Erythema	2.0% 1/50 • Number of events 1 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.	0.00% 0/46 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.
Skin and subcutaneous tissue disorders Skin Exfoliation	2.0% 1/50 • Number of events 1 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.	0.00% 0/46 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.
General disorders Pyrexia	2.0% 1/50 • Number of events 1 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.	0.00% 0/46 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.
Injury, poisoning and procedural complications Arthropod Bite	2.0% 1/50 • Number of events 1 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.	0.00% 0/46 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	2.0% 1/50 • Number of events 1 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.	0.00% 0/46 • 19 days Adverse event reporting was performed on the safety population (N=96). The safety population included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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