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

Split-face Tolerability Comparison Between Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Versus Retin-A Micro® (Tretinoin Gel) Microsphere, 0.1% in Subjects With Acne Vulgaris

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01522456

Enrollment

Registered

2012-01-31

Start date

2012-04-30

Completion date

2012-05-31

Last updated

2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

Detailed description

Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Interventions

DRUGEpiduo Gel

Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.

DRUGRetin-A Micro Microsphere 0.1%

Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female subjects of any race * Subjects 18 years or older * Subjects with acne vulgaris

Exclusion criteria

* Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%) * Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids) * Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids) * Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area * Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)

Design outcomes

Primary

Measure	Time frame	Description
Worst Postbaseline Tolerability (Dryness)	Day 1 - Day 22	Worst postbaseline tolerability assessments for dryness.
Worst Postbaseline Tolerability (Stinging/Burning)	Day 1 - Day 22	Worst postbaseline tolerability assessments for stinging/burning
Worst Postbaseline Tolerability (Scaling)	Day 1 - Day 22	Worst postbaseline assessment for scaling.
Worst Postbaseline Tolerability (Erythema)	Day 1 - Day 22	Worst postbaseline tolerability assessment for erythema.

Secondary

Measure	Time frame	Description
Tolerability at Day 22 (Stinging/Burning)	Day 22	Tolerability assessments at day 22 for stinging/burning
Cumulative Tolerability (Erythema)	Day 1 - Day 22	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.
Cumulative Tolerability (Dryness)	Day 1 - Day 22	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.
Cumulative Tolerability (Stinging/Burning)	Day 1 - Day 22	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.
Cumulative Tolerability (Combined)	Day 1 - Day 22	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.
Cumulative Tolerability (Scaling)	Day 1 - Day 22	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.
Tolerability at Day 22 (Erythema)	Day 22	Tolerability assessments at day 22 for erythema
Tolerability at Day 22 (Dryness)	Day 22	Tolerability assessments at day 22 for dryness
Tolerability at Day 22 (Scaling)	Day 22	Tolerability assessments at day 22 for scaling

Other

Measure	Time frame	Description
User Preference Survey (Investigator)	Day 5, day 12, day 19, and day 22	Response from investigator when asked: Which side of the face appears to be less irritated? Data collected from available participants.
Overall Tolerability Preference Survey	Day 22	Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.
User Preference Survey (Subjects)	Day 5, day 12, day 19, and day 22	Response from subjects when asked: Which side of the face feels less irritated? Data collected from available participants on each assessment day.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	73
Total	73

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	2
Overall Study	Lost to Follow-up	2
Overall Study	Pregnancy	1
Overall Study	Tolerability Assessment	1
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Total Participants
Age, Continuous	30.8 years STANDARD_DEVIATION 9.57
Sex: Female, Male Female	53 Participants
Sex: Female, Male Male	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	16 / 73	16 / 73	0 / 73
serious Total, serious adverse events	0 / 73	0 / 73	1 / 73

Outcome results

Primary

Worst Postbaseline Tolerability (Dryness)

Worst postbaseline tolerability assessments for dryness.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Worst Postbaseline Tolerability (Dryness)	None	34 participants
Epiduo Gel	Worst Postbaseline Tolerability (Dryness)	Mild	35 participants
Epiduo Gel	Worst Postbaseline Tolerability (Dryness)	Moderate	4 participants
Epiduo Gel	Worst Postbaseline Tolerability (Dryness)	Severe	0 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Dryness)	Severe	0 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Dryness)	None	28 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Dryness)	Moderate	4 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Dryness)	Mild	41 participants

Primary

Worst Postbaseline Tolerability (Erythema)

Worst postbaseline tolerability assessment for erythema.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Worst Postbaseline Tolerability (Erythema)	None	25 participants
Epiduo Gel	Worst Postbaseline Tolerability (Erythema)	Mild	27 participants
Epiduo Gel	Worst Postbaseline Tolerability (Erythema)	Moderate	19 participants
Epiduo Gel	Worst Postbaseline Tolerability (Erythema)	Severe	2 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Erythema)	Severe	2 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Erythema)	None	28 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Erythema)	Moderate	19 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Erythema)	Mild	24 participants

Primary

Worst Postbaseline Tolerability (Scaling)

Worst postbaseline assessment for scaling.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Worst Postbaseline Tolerability (Scaling)	None	25 participants
Epiduo Gel	Worst Postbaseline Tolerability (Scaling)	Mild	34 participants
Epiduo Gel	Worst Postbaseline Tolerability (Scaling)	Moderate	14 participants
Epiduo Gel	Worst Postbaseline Tolerability (Scaling)	Severe	0 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Scaling)	Severe	0 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Scaling)	None	18 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Scaling)	Moderate	12 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Scaling)	Mild	43 participants

Primary

Worst Postbaseline Tolerability (Stinging/Burning)

Worst postbaseline tolerability assessments for stinging/burning

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Worst Postbaseline Tolerability (Stinging/Burning)	None	51 participants
Epiduo Gel	Worst Postbaseline Tolerability (Stinging/Burning)	Mild	18 participants
Epiduo Gel	Worst Postbaseline Tolerability (Stinging/Burning)	Moderate	3 participants
Epiduo Gel	Worst Postbaseline Tolerability (Stinging/Burning)	Severe	1 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Stinging/Burning)	Severe	0 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Stinging/Burning)	None	57 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Stinging/Burning)	Moderate	2 participants
Retin-A Micro Microsphere 0.1%	Worst Postbaseline Tolerability (Stinging/Burning)	Mild	14 participants

Secondary

Cumulative Tolerability (Combined)

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.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Cumulative Tolerability (Combined)	1	29 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	2	60 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	3	98 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	4	148 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	5	212 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	8	298 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	9	392 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	10	510 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	11	613 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	12	740 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	15	834 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	16	914 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	17	995 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	18	1068 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	19	1144 scores on a scale
Epiduo Gel	Cumulative Tolerability (Combined)	22	1220 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	22	1158 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	1	27 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	11	531 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	2	55 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	17	914 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	3	86 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	12	663 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	4	127 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	19	1073 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	5	187 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	15	756 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	8	250 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	18	994 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	9	324 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	16	835 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Combined)	10	427 scores on a scale

Secondary

Cumulative Tolerability (Dryness)

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.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Cumulative Tolerability (Dryness)	1	2 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	2	3 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	3	6 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	4	11 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	5	18 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	8	30 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	9	48 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	10	73 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	11	99 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	12	128 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	15	152 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	16	178 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	17	205 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	18	231 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	19	256 scores on a scale
Epiduo Gel	Cumulative Tolerability (Dryness)	22	281 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	22	271 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	1	1 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	11	76 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	2	2 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	17	188 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	3	2 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	12	107 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	4	4 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	19	242 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	5	6 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	15	134 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	8	11 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	18	215 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	9	22 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	16	162 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Dryness)	10	49 scores on a scale

Secondary

Cumulative Tolerability (Erythema)

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.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Cumulative Tolerability (Erythema)	1	26 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	11	323 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	5	164 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	12	370 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	3	86 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	15	410 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	8	207 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	16	447 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	2	56 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	17	483 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	9	244 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	18	517 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	19	550 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	4	122 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	22	583 scores on a scale
Epiduo Gel	Cumulative Tolerability (Erythema)	10	287 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	22	529 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	1	26 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	2	52 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	3	79 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	4	111 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	5	149 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	8	187 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	9	218 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	10	250 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	11	286 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	12	334 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	15	368 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	16	400 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	17	433 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	19	495 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Erythema)	18	464 scores on a scale

Secondary

Cumulative Tolerability (Scaling)

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.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Cumulative Tolerability (Scaling)	1	1 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	2	1 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	3	5 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	4	11 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	5	21 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	8	44 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	9	71 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	10	108 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	11	141 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	12	182 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	15	211 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	16	228 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	17	246 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	18	259 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	19	277 scores on a scale
Epiduo Gel	Cumulative Tolerability (Scaling)	22	295 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	22	325 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	1	0 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	11	144 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	2	0 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	17	260 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	3	3 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	12	190 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	4	9 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	19	303 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	5	26 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	15	221 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	8	44 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	18	282 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	9	71 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	16	240 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Scaling)	10	108 scores on a scale

Secondary

Cumulative Tolerability (Stinging/Burning)

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.

Time frame: Day 1 - Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	10	42 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	11	50 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	9	29 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	1	0 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	2	0 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	3	1 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	4	4 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	5	9 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	8	17 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	12	60 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	15	61 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	16	61 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	17	61 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	18	61 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	19	61 scores on a scale
Epiduo Gel	Cumulative Tolerability (Stinging/Burning)	22	61 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	22	33 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	10	20 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	8	8 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	11	25 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	17	33 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	9	13 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	12	32 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	1	0 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	19	33 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	2	1 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	15	33 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	3	2 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	18	33 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	4	3 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	16	33 scores on a scale
Retin-A Micro Microsphere 0.1%	Cumulative Tolerability (Stinging/Burning)	5	6 scores on a scale

Secondary

Tolerability at Day 22 (Dryness)

Tolerability assessments at day 22 for dryness

Time frame: Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Tolerability at Day 22 (Dryness)	Severe	0 participants
Epiduo Gel	Tolerability at Day 22 (Dryness)	Data Missing	4 participants
Epiduo Gel	Tolerability at Day 22 (Dryness)	None	44 participants
Epiduo Gel	Tolerability at Day 22 (Dryness)	Mild	25 participants
Epiduo Gel	Tolerability at Day 22 (Dryness)	Moderate	0 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Dryness)	Moderate	0 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Dryness)	Mild	29 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Dryness)	Data Missing	4 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Dryness)	Severe	0 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Dryness)	None	40 participants

Secondary

Tolerability at Day 22 (Erythema)

Tolerability assessments at day 22 for erythema

Time frame: Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Tolerability at Day 22 (Erythema)	Severe	0 participants
Epiduo Gel	Tolerability at Day 22 (Erythema)	None	36 participants
Epiduo Gel	Tolerability at Day 22 (Erythema)	Mild	33 participants
Epiduo Gel	Tolerability at Day 22 (Erythema)	Moderate	0 participants
Epiduo Gel	Tolerability at Day 22 (Erythema)	Data Missing	4 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Erythema)	Data Missing	4 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Erythema)	Moderate	3 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Erythema)	None	38 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Erythema)	Severe	0 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Erythema)	Mild	28 participants

Secondary

Tolerability at Day 22 (Scaling)

Tolerability assessments at day 22 for scaling

Time frame: Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Tolerability at Day 22 (Scaling)	Mild	12 participants
Epiduo Gel	Tolerability at Day 22 (Scaling)	Severe	0 participants
Epiduo Gel	Tolerability at Day 22 (Scaling)	Moderate	3 participants
Epiduo Gel	Tolerability at Day 22 (Scaling)	Data Missing	4 participants
Epiduo Gel	Tolerability at Day 22 (Scaling)	None	54 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Scaling)	Data Missing	4 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Scaling)	None	48 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Scaling)	Mild	20 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Scaling)	Moderate	1 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Scaling)	Severe	0 participants

Secondary

Tolerability at Day 22 (Stinging/Burning)

Tolerability assessments at day 22 for stinging/burning

Time frame: Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Tolerability at Day 22 (Stinging/Burning)	Mild	0 participants
Epiduo Gel	Tolerability at Day 22 (Stinging/Burning)	Severe	0 participants
Epiduo Gel	Tolerability at Day 22 (Stinging/Burning)	Moderate	0 participants
Epiduo Gel	Tolerability at Day 22 (Stinging/Burning)	Data Missing	4 participants
Epiduo Gel	Tolerability at Day 22 (Stinging/Burning)	None	69 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Stinging/Burning)	Data Missing	4 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Stinging/Burning)	None	69 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Stinging/Burning)	Mild	0 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Stinging/Burning)	Moderate	0 participants
Retin-A Micro Microsphere 0.1%	Tolerability at Day 22 (Stinging/Burning)	Severe	0 participants

Post Hoc

Fitzpatrick Skin Type Overall Tolerability Preference Survey Results

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.

Time frame: Day 22

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference-investigator	21 participants
Epiduo Gel	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference - subject	21 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference - subject	19 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference-investigator	19 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference-investigator	20 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference - subject	18 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference-investigator	12 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results	Overall tolerability preference - subject	14 participants

Post Hoc

Fitzpatrick Skin Type User Preference Survey at 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.

Time frame: Day 22

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Fitzpatrick Skin Type User Preference Survey at Day 22	Left less residue	25 participants
Epiduo Gel	Fitzpatrick Skin Type User Preference Survey at Day 22	Absorbed more quickly	22 participants
Epiduo Gel	Fitzpatrick Skin Type User Preference Survey at Day 22	Overall	20 participants
Epiduo Gel	Fitzpatrick Skin Type User Preference Survey at Day 22	Smelled better	20 participants
Epiduo Gel	Fitzpatrick Skin Type User Preference Survey at Day 22	Felt better	15 participants
Epiduo Gel	Fitzpatrick Skin Type User Preference Survey at Day 22	Spread more easily	22 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type User Preference Survey at Day 22	Smelled better	19 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type User Preference Survey at Day 22	Spread more easily	17 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type User Preference Survey at Day 22	Left less residue	14 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type User Preference Survey at Day 22	Felt better	24 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type User Preference Survey at Day 22	Overall	19 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type User Preference Survey at Day 22	Absorbed more quickly	17 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Overall	24 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Absorbed more quickly	23 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Felt better	22 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Smelled better	19 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Spread more easily	27 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Left less residue	25 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Smelled better	13 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Spread more easily	5 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Absorbed more quickly	9 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Overall	8 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Felt better	10 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type User Preference Survey at Day 22	Left less residue	7 participants

Post Hoc

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)

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).

Time frame: Day 1 - Day 22

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	None	13 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Moderate	2 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Mild	26 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	None	14 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Moderate	2 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Mild	25 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Mild	9 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	None	21 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Moderate	2 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	None	14 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Moderate	2 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)	Mild	16 participants

Post Hoc

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)

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).

Time frame: Day 1 - Day 22

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	None	5 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Mild	18 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Moderate	16 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Severe	2 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Mild	17 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Severe	2 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	None	7 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Moderate	15 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Moderate	3 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Severe	0 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	None	20 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Mild	9 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Severe	0 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	None	21 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Mild	7 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)	Moderate	4 participants

Post Hoc

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)

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).

Time frame: Day 1 - Day 22

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	None	13 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Moderate	9 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Mild	19 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	None	10 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Moderate	9 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Mild	22 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Mild	15 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	None	12 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Moderate	5 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	None	8 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Moderate	3 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)	Mild	21 participants

Post Hoc

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)

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).

Time frame: Day 1 - Day 22

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Severe	1 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Mild	9 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	None	28 participants
Epiduo Gel	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Moderate	3 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Mild	10 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Moderate	2 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	None	29 participants
Retin-A Micro Microsphere 0.1%	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Severe	0 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	None	23 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Mild	9 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Moderate	0 participants
Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Severe	0 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Mild	4 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	None	28 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Severe	0 participants
Retin-A Micro (Fitzpatrick Skin Types IV-VI)	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)	Moderate	0 participants

Other Pre-specified

Overall Tolerability Preference Survey

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

Time frame: Day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	Overall Tolerability Preference Survey	____ spread easier (n=71)	49 participants
Epiduo Gel	Overall Tolerability Preference Survey	____ had a more pleasant smell (n=71)	39 participants
Epiduo Gel	Overall Tolerability Preference Survey	____ left smaller amount of residue on skin (n=71)	50 participants
Epiduo Gel	Overall Tolerability Preference Survey	____ absorbed quicker into my skin (n=71)	45 participants
Epiduo Gel	Overall Tolerability Preference Survey	Overall, I prefer ____ (n=71)	44 participants
Epiduo Gel	Overall Tolerability Preference Survey	____ felt better on my skin (n=71)	37 participants
Retin-A Micro Microsphere 0.1%	Overall Tolerability Preference Survey	Overall, I prefer ____ (n=71)	27 participants
Retin-A Micro Microsphere 0.1%	Overall Tolerability Preference Survey	____ felt better on my skin (n=71)	34 participants
Retin-A Micro Microsphere 0.1%	Overall Tolerability Preference Survey	____ spread easier (n=71)	22 participants
Retin-A Micro Microsphere 0.1%	Overall Tolerability Preference Survey	____ absorbed quicker into my skin (n=71)	26 participants
Retin-A Micro Microsphere 0.1%	Overall Tolerability Preference Survey	____ had a more pleasant smell (n=71)	32 participants
Retin-A Micro Microsphere 0.1%	Overall Tolerability Preference Survey	____ left smaller amount of residue on skin (n=71)	21 participants

Other Pre-specified

User Preference Survey (Investigator)

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

Time frame: Day 5, day 12, day 19, and day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	User Preference Survey (Investigator)	Day 5 (n=69)	34 participants
Epiduo Gel	User Preference Survey (Investigator)	Day 12 (n=67)	34 participants
Epiduo Gel	User Preference Survey (Investigator)	Day 19 (n=65)	37 participants
Epiduo Gel	User Preference Survey (Investigator)	Day 22 (n=72)	41 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Investigator)	Day 22 (n=72)	31 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Investigator)	Day 5 (n=69)	35 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Investigator)	Day 19 (n=65)	28 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Investigator)	Day 12 (n=67)	33 participants

Other Pre-specified

User Preference Survey (Subjects)

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

Time frame: Day 5, day 12, day 19, and day 22

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Epiduo Gel	User Preference Survey (Subjects)	Day 5 (n=69)	42 participants
Epiduo Gel	User Preference Survey (Subjects)	Day 12 (n=67)	33 participants
Epiduo Gel	User Preference Survey (Subjects)	Day 19 (n=65)	36 participants
Epiduo Gel	User Preference Survey (Subjects)	Day 22 (n=72)	39 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Subjects)	Day 22 (n=72)	33 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Subjects)	Day 5 (n=69)	27 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Subjects)	Day 19 (n=65)	29 participants
Retin-A Micro Microsphere 0.1%	User Preference Survey (Subjects)	Day 12 (n=67)	34 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Worst Postbaseline Tolerability (Dryness)

Worst Postbaseline Tolerability (Erythema)

Worst Postbaseline Tolerability (Scaling)

Worst Postbaseline Tolerability (Stinging/Burning)

Cumulative Tolerability (Combined)

Cumulative Tolerability (Dryness)

Cumulative Tolerability (Erythema)

Cumulative Tolerability (Scaling)

Cumulative Tolerability (Stinging/Burning)

Tolerability at Day 22 (Dryness)

Tolerability at Day 22 (Erythema)

Tolerability at Day 22 (Scaling)

Tolerability at Day 22 (Stinging/Burning)

Fitzpatrick Skin Type Overall Tolerability Preference Survey Results

Fitzpatrick Skin Type User Preference Survey at Day 22

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)

Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)

Overall Tolerability Preference Survey

User Preference Survey (Investigator)

User Preference Survey (Subjects)