Trial Outcomes & Findings for Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel (NCT NCT01522456)

NCT ID: NCT01522456

Last Updated: 2022-08-01

Results Overview

Worst postbaseline tolerability assessment for erythema.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 73 participants
• Primary outcome timeframe: Day 1 - Day 22
• Results posted on: 2022-08-01

Participant Flow

Participant milestones

Measure	Total Participants All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
Overall Study STARTED	73
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Total Participants All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2
Overall Study Pregnancy	1
Overall Study Tolerability Assessment	1

Baseline Characteristics

Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel

Baseline characteristics by cohort

Measure	Total Participants n=73 Participants All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
Age, Continuous	30.8 years STANDARD_DEVIATION 9.57 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Worst postbaseline tolerability assessment for erythema.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Worst Postbaseline Tolerability (Erythema) Mild	27 participants	24 participants	—	—
Worst Postbaseline Tolerability (Erythema) None	25 participants	28 participants	—	—
Worst Postbaseline Tolerability (Erythema) Moderate	19 participants	19 participants	—	—
Worst Postbaseline Tolerability (Erythema) Severe	2 participants	2 participants	—	—

PRIMARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Worst postbaseline assessment for scaling.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Worst Postbaseline Tolerability (Scaling) None	25 participants	18 participants	—	—
Worst Postbaseline Tolerability (Scaling) Mild	34 participants	43 participants	—	—
Worst Postbaseline Tolerability (Scaling) Moderate	14 participants	12 participants	—	—
Worst Postbaseline Tolerability (Scaling) Severe	0 participants	0 participants	—	—

PRIMARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Worst postbaseline tolerability assessments for dryness.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Worst Postbaseline Tolerability (Dryness) Moderate	4 participants	4 participants	—	—
Worst Postbaseline Tolerability (Dryness) None	34 participants	28 participants	—	—
Worst Postbaseline Tolerability (Dryness) Mild	35 participants	41 participants	—	—
Worst Postbaseline Tolerability (Dryness) Severe	0 participants	0 participants	—	—

PRIMARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Worst postbaseline tolerability assessments for stinging/burning

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Worst Postbaseline Tolerability (Stinging/Burning) None	51 participants	57 participants	—	—
Worst Postbaseline Tolerability (Stinging/Burning) Mild	18 participants	14 participants	—	—
Worst Postbaseline Tolerability (Stinging/Burning) Moderate	3 participants	2 participants	—	—
Worst Postbaseline Tolerability (Stinging/Burning) Severe	1 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Day 22

Population: Safety population

Tolerability assessments at day 22 for erythema

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Tolerability at Day 22 (Erythema) None	36 participants	38 participants	—	—
Tolerability at Day 22 (Erythema) Mild	33 participants	28 participants	—	—
Tolerability at Day 22 (Erythema) Moderate	0 participants	3 participants	—	—
Tolerability at Day 22 (Erythema) Severe	0 participants	0 participants	—	—
Tolerability at Day 22 (Erythema) Data Missing	4 participants	4 participants	—	—

SECONDARY outcome

Timeframe: Day 22

Population: Safety population

Tolerability assessments at day 22 for dryness

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Tolerability at Day 22 (Dryness) None	44 participants	40 participants	—	—
Tolerability at Day 22 (Dryness) Mild	25 participants	29 participants	—	—
Tolerability at Day 22 (Dryness) Moderate	0 participants	0 participants	—	—
Tolerability at Day 22 (Dryness) Severe	0 participants	0 participants	—	—
Tolerability at Day 22 (Dryness) Data Missing	4 participants	4 participants	—	—

SECONDARY outcome

Timeframe: Day 22

Population: Safety population

Tolerability assessments at day 22 for scaling

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Tolerability at Day 22 (Scaling) None	54 participants	48 participants	—	—
Tolerability at Day 22 (Scaling) Mild	12 participants	20 participants	—	—
Tolerability at Day 22 (Scaling) Moderate	3 participants	1 participants	—	—
Tolerability at Day 22 (Scaling) Severe	0 participants	0 participants	—	—
Tolerability at Day 22 (Scaling) Data Missing	4 participants	4 participants	—	—

SECONDARY outcome

Timeframe: Day 22

Population: Safety population

Tolerability assessments at day 22 for stinging/burning

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Tolerability at Day 22 (Stinging/Burning) None	69 participants	69 participants	—	—
Tolerability at Day 22 (Stinging/Burning) Mild	0 participants	0 participants	—	—
Tolerability at Day 22 (Stinging/Burning) Moderate	0 participants	0 participants	—	—
Tolerability at Day 22 (Stinging/Burning) Severe	0 participants	0 participants	—	—
Tolerability at Day 22 (Stinging/Burning) Data Missing	4 participants	4 participants	—	—

SECONDARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Cumulative Tolerability (Erythema) 1	26 scores on a scale	26 scores on a scale	—	—
Cumulative Tolerability (Erythema) 2	56 scores on a scale	52 scores on a scale	—	—
Cumulative Tolerability (Erythema) 3	86 scores on a scale	79 scores on a scale	—	—
Cumulative Tolerability (Erythema) 4	122 scores on a scale	111 scores on a scale	—	—
Cumulative Tolerability (Erythema) 5	164 scores on a scale	149 scores on a scale	—	—
Cumulative Tolerability (Erythema) 8	207 scores on a scale	187 scores on a scale	—	—
Cumulative Tolerability (Erythema) 9	244 scores on a scale	218 scores on a scale	—	—
Cumulative Tolerability (Erythema) 10	287 scores on a scale	250 scores on a scale	—	—
Cumulative Tolerability (Erythema) 11	323 scores on a scale	286 scores on a scale	—	—
Cumulative Tolerability (Erythema) 12	370 scores on a scale	334 scores on a scale	—	—
Cumulative Tolerability (Erythema) 15	410 scores on a scale	368 scores on a scale	—	—
Cumulative Tolerability (Erythema) 16	447 scores on a scale	400 scores on a scale	—	—
Cumulative Tolerability (Erythema) 17	483 scores on a scale	433 scores on a scale	—	—
Cumulative Tolerability (Erythema) 18	517 scores on a scale	464 scores on a scale	—	—
Cumulative Tolerability (Erythema) 19	550 scores on a scale	495 scores on a scale	—	—
Cumulative Tolerability (Erythema) 22	583 scores on a scale	529 scores on a scale	—	—

SECONDARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Cumulative Tolerability (Scaling) 1	1 scores on a scale	0 scores on a scale	—	—
Cumulative Tolerability (Scaling) 2	1 scores on a scale	0 scores on a scale	—	—
Cumulative Tolerability (Scaling) 3	5 scores on a scale	3 scores on a scale	—	—
Cumulative Tolerability (Scaling) 4	11 scores on a scale	9 scores on a scale	—	—
Cumulative Tolerability (Scaling) 5	21 scores on a scale	26 scores on a scale	—	—
Cumulative Tolerability (Scaling) 8	44 scores on a scale	44 scores on a scale	—	—
Cumulative Tolerability (Scaling) 9	71 scores on a scale	71 scores on a scale	—	—
Cumulative Tolerability (Scaling) 10	108 scores on a scale	108 scores on a scale	—	—
Cumulative Tolerability (Scaling) 11	141 scores on a scale	144 scores on a scale	—	—
Cumulative Tolerability (Scaling) 12	182 scores on a scale	190 scores on a scale	—	—
Cumulative Tolerability (Scaling) 15	211 scores on a scale	221 scores on a scale	—	—
Cumulative Tolerability (Scaling) 16	228 scores on a scale	240 scores on a scale	—	—
Cumulative Tolerability (Scaling) 17	246 scores on a scale	260 scores on a scale	—	—
Cumulative Tolerability (Scaling) 18	259 scores on a scale	282 scores on a scale	—	—
Cumulative Tolerability (Scaling) 19	277 scores on a scale	303 scores on a scale	—	—
Cumulative Tolerability (Scaling) 22	295 scores on a scale	325 scores on a scale	—	—

SECONDARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Cumulative Tolerability (Dryness) 1	2 scores on a scale	1 scores on a scale	—	—
Cumulative Tolerability (Dryness) 2	3 scores on a scale	2 scores on a scale	—	—
Cumulative Tolerability (Dryness) 3	6 scores on a scale	2 scores on a scale	—	—
Cumulative Tolerability (Dryness) 4	11 scores on a scale	4 scores on a scale	—	—
Cumulative Tolerability (Dryness) 5	18 scores on a scale	6 scores on a scale	—	—
Cumulative Tolerability (Dryness) 8	30 scores on a scale	11 scores on a scale	—	—
Cumulative Tolerability (Dryness) 9	48 scores on a scale	22 scores on a scale	—	—
Cumulative Tolerability (Dryness) 10	73 scores on a scale	49 scores on a scale	—	—
Cumulative Tolerability (Dryness) 11	99 scores on a scale	76 scores on a scale	—	—
Cumulative Tolerability (Dryness) 12	128 scores on a scale	107 scores on a scale	—	—
Cumulative Tolerability (Dryness) 15	152 scores on a scale	134 scores on a scale	—	—
Cumulative Tolerability (Dryness) 16	178 scores on a scale	162 scores on a scale	—	—
Cumulative Tolerability (Dryness) 17	205 scores on a scale	188 scores on a scale	—	—
Cumulative Tolerability (Dryness) 18	231 scores on a scale	215 scores on a scale	—	—
Cumulative Tolerability (Dryness) 19	256 scores on a scale	242 scores on a scale	—	—
Cumulative Tolerability (Dryness) 22	281 scores on a scale	271 scores on a scale	—	—

SECONDARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Cumulative Tolerability (Stinging/Burning) 12	60 scores on a scale	32 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 1	0 scores on a scale	0 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 2	0 scores on a scale	1 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 3	1 scores on a scale	2 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 4	4 scores on a scale	3 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 5	9 scores on a scale	6 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 8	17 scores on a scale	8 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 9	29 scores on a scale	13 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 10	42 scores on a scale	20 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 11	50 scores on a scale	25 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 15	61 scores on a scale	33 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 16	61 scores on a scale	33 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 17	61 scores on a scale	33 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 18	61 scores on a scale	33 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 19	61 scores on a scale	33 scores on a scale	—	—
Cumulative Tolerability (Stinging/Burning) 22	61 scores on a scale	33 scores on a scale	—	—

SECONDARY outcome

Timeframe: Day 1 - Day 22

Population: Safety population

Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Cumulative Tolerability (Combined) 2	60 scores on a scale	55 scores on a scale	—	—
Cumulative Tolerability (Combined) 3	98 scores on a scale	86 scores on a scale	—	—
Cumulative Tolerability (Combined) 4	148 scores on a scale	127 scores on a scale	—	—
Cumulative Tolerability (Combined) 5	212 scores on a scale	187 scores on a scale	—	—
Cumulative Tolerability (Combined) 8	298 scores on a scale	250 scores on a scale	—	—
Cumulative Tolerability (Combined) 9	392 scores on a scale	324 scores on a scale	—	—
Cumulative Tolerability (Combined) 10	510 scores on a scale	427 scores on a scale	—	—
Cumulative Tolerability (Combined) 11	613 scores on a scale	531 scores on a scale	—	—
Cumulative Tolerability (Combined) 12	740 scores on a scale	663 scores on a scale	—	—
Cumulative Tolerability (Combined) 15	834 scores on a scale	756 scores on a scale	—	—
Cumulative Tolerability (Combined) 16	914 scores on a scale	835 scores on a scale	—	—
Cumulative Tolerability (Combined) 17	995 scores on a scale	914 scores on a scale	—	—
Cumulative Tolerability (Combined) 18	1068 scores on a scale	994 scores on a scale	—	—
Cumulative Tolerability (Combined) 19	1144 scores on a scale	1073 scores on a scale	—	—
Cumulative Tolerability (Combined) 22	1220 scores on a scale	1158 scores on a scale	—	—
Cumulative Tolerability (Combined) 1	29 scores on a scale	27 scores on a scale	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 5, day 12, day 19, and day 22

Population: Safety population

Response from investigator when asked: "Which side of the face appears to be less irritated?" Data collected from available participants.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
User Preference Survey (Investigator) Day 5 (n=69)	34 participants	35 participants	—	—
User Preference Survey (Investigator) Day 12 (n=67)	34 participants	33 participants	—	—
User Preference Survey (Investigator) Day 19 (n=65)	37 participants	28 participants	—	—
User Preference Survey (Investigator) Day 22 (n=72)	41 participants	31 participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 5, day 12, day 19, and day 22

Population: Safety population

Response from subjects when asked: "Which side of the face feels less irritated?" Data collected from available participants on each assessment day.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
User Preference Survey (Subjects) Day 5 (n=69)	42 participants	27 participants	—	—
User Preference Survey (Subjects) Day 12 (n=67)	33 participants	34 participants	—	—
User Preference Survey (Subjects) Day 19 (n=65)	36 participants	29 participants	—	—
User Preference Survey (Subjects) Day 22 (n=72)	39 participants	33 participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 22

Population: Safety population

Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.

Outcome measures

Measure	Epiduo Gel n=73 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Overall Tolerability Preference Survey ____ spread easier (n=71)	49 participants	22 participants	—	—
Overall Tolerability Preference Survey ____ absorbed quicker into my skin (n=71)	45 participants	26 participants	—	—
Overall Tolerability Preference Survey ____ had a more pleasant smell (n=71)	39 participants	32 participants	—	—
Overall Tolerability Preference Survey ____ felt better on my skin (n=71)	37 participants	34 participants	—	—
Overall Tolerability Preference Survey ____ left smaller amount of residue on skin (n=71)	50 participants	21 participants	—	—
Overall Tolerability Preference Survey Overall, I prefer ____ (n=71)	44 participants	27 participants	—	—

POST_HOC outcome

Timeframe: Day 1 - Day 22

Population: Safety Population

Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Erythema. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).

Outcome measures

Measure	Epiduo Gel n=41 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=41 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) n=32 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) n=32 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema) None	5 participants	7 participants	20 participants	21 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema) Mild	18 participants	17 participants	9 participants	7 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema) Moderate	16 participants	15 participants	3 participants	4 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema) Severe	2 participants	2 participants	0 participants	0 participants

POST_HOC outcome

Timeframe: Day 1 - Day 22

Population: Safety Population

Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Scaling. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).

Outcome measures

Measure	Epiduo Gel n=41 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=41 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) n=32 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) n=32 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling) Mild	19 participants	22 participants	15 participants	21 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling) Moderate	9 participants	9 participants	5 participants	3 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling) None	13 participants	10 participants	12 participants	8 participants

POST_HOC outcome

Timeframe: Day 1 - Day 22

Population: Safety Population

Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Dryness. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).

Outcome measures

Measure	Epiduo Gel n=41 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=41 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) n=32 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) n=32 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness) None	13 participants	14 participants	21 participants	14 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness) Mild	26 participants	25 participants	9 participants	16 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness) Moderate	2 participants	2 participants	2 participants	2 participants

POST_HOC outcome

Timeframe: Day 1 - Day 22

Population: Safety Population

Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Stinging/Burning. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).

Outcome measures

Measure	Epiduo Gel n=41 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=41 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) n=32 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) n=32 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning) Mild	9 participants	10 participants	9 participants	4 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning) Moderate	3 participants	2 participants	0 participants	0 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning) Severe	1 participants	0 participants	0 participants	0 participants
Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning) None	28 participants	29 participants	23 participants	28 participants

POST_HOC outcome

Timeframe: Day 22

User Preference Survey at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type. Fitzpatrick skin type (FST) is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). Two subjects did not participate in the User Preference Survey; as a result, 2 subjects were not included in the FST I - III group results below.

Outcome measures

Measure	Epiduo Gel n=39 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=39 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) n=32 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) n=32 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Fitzpatrick Skin Type User Preference Survey at Day 22 Spread more easily	22 participants	17 participants	27 participants	5 participants
Fitzpatrick Skin Type User Preference Survey at Day 22 Absorbed more quickly	22 participants	17 participants	23 participants	9 participants
Fitzpatrick Skin Type User Preference Survey at Day 22 Smelled better	20 participants	19 participants	19 participants	13 participants
Fitzpatrick Skin Type User Preference Survey at Day 22 Felt better	15 participants	24 participants	22 participants	10 participants
Fitzpatrick Skin Type User Preference Survey at Day 22 Left less residue	25 participants	14 participants	25 participants	7 participants
Fitzpatrick Skin Type User Preference Survey at Day 22 Overall	20 participants	19 participants	24 participants	8 participants

POST_HOC outcome

Timeframe: Day 22

Overall Tolerability Preference Survey Results at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type (FST). Data collected from available subjects on day 22. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). One subject did not participate in the User Preference Survey; as a result, 1 subject was not included in the FST I - III group results below.

Outcome measures

Measure	Epiduo Gel n=40 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=40 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Epiduo Gel (Fitzpatrick Skin Types IV-VI) n=32 Participants Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro (Fitzpatrick Skin Types IV-VI) n=32 Participants Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Fitzpatrick Skin Type Overall Tolerability Preference Survey Results Overall tolerability preference-investigator	21 participants	19 participants	20 participants	12 participants
Fitzpatrick Skin Type Overall Tolerability Preference Survey Results Overall tolerability preference - subject	21 participants	19 participants	18 participants	14 participants

Adverse Events

Epiduo Gel

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Retin-A Micro Microsphere 0.1%

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Non-application Site

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Epiduo Gel n=73 participants at risk Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 participants at risk Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Non-application Site n=73 participants at risk Adverse events occurring on non-application sites
Nervous system disorders Epilepsy	0.00% 0/73 • Day 1 - Day 22	0.00% 0/73 • Day 1 - Day 22	1.4% 1/73 • Number of events 1 • Day 1 - Day 22

Other adverse events

Measure	Epiduo Gel n=73 participants at risk Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.	Retin-A Micro Microsphere 0.1% n=73 participants at risk Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.	Non-application Site n=73 participants at risk Adverse events occurring on non-application sites
Skin and subcutaneous tissue disorders Dry Skin	19.2% 14/73 • Number of events 14 • Day 1 - Day 22	20.5% 15/73 • Number of events 15 • Day 1 - Day 22	0.00% 0/73 • Day 1 - Day 22
Skin and subcutaneous tissue disorders Skin Burning Sensation	5.5% 4/73 • Number of events 4 • Day 1 - Day 22	2.7% 2/73 • Number of events 2 • Day 1 - Day 22	0.00% 0/73 • Day 1 - Day 22

Additional Information

Elizabeth M. Nieman, Associate Medical Information Specialist

Galderma Laboratories, L.P.

Phone: 817-961-5130

Email: elizabeth.nieman@galderma.com

Results disclosure agreements

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

Restriction type: LTE60