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

• Sponsor: Galderma Laboratories, L.P. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01522456
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 74.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Epiduo Gel; Drug: Retin-A Micro Microsphere 0.1%	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Epiduo Gel Adapalene 0.1% and benzoyl peroxide 2.5% gel	Drug: Epiduo Gel; Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.
Active Comparator: Retin-A Micro Microsphere 0.1% Tretinoin gel, 0.1%	Drug: Retin-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.

Outcome Measures

Primary Outcome Measures

1. Worst Postbaseline Tolerability (Erythema) [Day 1 - Day 22]

   Worst postbaseline tolerability assessment for erythema.

2. Worst Postbaseline Tolerability (Scaling) [Day 1 - Day 22]

   Worst postbaseline assessment for scaling.

3. Worst Postbaseline Tolerability (Dryness) [Day 1 - Day 22]

   Worst postbaseline tolerability assessments for dryness.

4. Worst Postbaseline Tolerability (Stinging/Burning) [Day 1 - Day 22]

   Worst postbaseline tolerability assessments for stinging/burning

Secondary Outcome Measures

1. Tolerability at Day 22 (Erythema) [Day 22]

   Tolerability assessments at day 22 for erythema

2. Tolerability at Day 22 (Dryness) [Day 22]

   Tolerability assessments at day 22 for dryness

3. Tolerability at Day 22 (Scaling) [Day 22]

   Tolerability assessments at day 22 for scaling

4. Tolerability at Day 22 (Stinging/Burning) [Day 22]

   Tolerability assessments at day 22 for stinging/burning

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

Other Outcome Measures

1. 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.

2. 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.

3. Overall Tolerability Preference Survey [Day 22]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stephens and Associates	Dallas	Texas	United States	75006

Sponsors and Collaborators

• Galderma Laboratories, L.P.

Investigators

• Study Director: Ronald Gottschalk, MD, Galderma Laboratories, L.P.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma Laboratories, L.P.
• ClinicalTrials.gov Identifier: NCT01522456
• Other Study ID Numbers: US10201
• First Posted: Jan 31, 2012
• Last Update Posted: Aug 18, 2015
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Acne Vulgaris; Tretinoin

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Total Participants
Arm/Group Description	All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
Overall Participants	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.8 (9.57)
Sex: Female, Male (Count of Participants)
Female	53 72.6%
Male	20 27.4%

Outcome Measures

1. Primary Outcome

Title	Worst Postbaseline Tolerability (Erythema)
Description	Worst postbaseline tolerability assessment for erythema.
Time Frame	Day 1 - Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	25 34.2%	28 NaN
Mild	27 37%	24 NaN
Moderate	19 26%	19 NaN
Severe	2 2.7%	2 NaN

2. Secondary Outcome

Title	Tolerability at Day 22 (Erythema)
Description	Tolerability assessments at day 22 for erythema
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	36 49.3%	38 NaN
Mild	33 45.2%	28 NaN
Moderate	0 0%	3 NaN
Severe	0 0%	0 NaN
Data Missing	4 5.5%	4 NaN

3. Secondary Outcome

Title	Tolerability at Day 22 (Dryness)
Description	Tolerability assessments at day 22 for dryness
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	44 60.3%	40 NaN
Mild	25 34.2%	29 NaN
Moderate	0 0%	0 NaN
Severe	0 0%	0 NaN
Data Missing	4 5.5%	4 NaN

4. Other Pre-specified Outcome

Title	User Preference Survey (Investigator)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
Day 5 (n=69)	34 46.6%	35 NaN
Day 12 (n=67)	34 46.6%	33 NaN
Day 19 (n=65)	37 50.7%	28 NaN
Day 22 (n=72)	41 56.2%	31 NaN

5. Other Pre-specified Outcome

Title	User Preference Survey (Subjects)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
Day 5 (n=69)	42 57.5%	27 NaN
Day 12 (n=67)	33 45.2%	34 NaN
Day 19 (n=65)	36 49.3%	29 NaN
Day 22 (n=72)	39 53.4%	33 NaN

6. Primary Outcome

Title	Worst Postbaseline Tolerability (Scaling)
Description	Worst postbaseline assessment for scaling.
Time Frame	Day 1 - Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	25 34.2%	18 NaN
Mild	34 46.6%	43 NaN
Moderate	14 19.2%	12 NaN
Severe	0 0%	0 NaN

7. Primary Outcome

Title	Worst Postbaseline Tolerability (Dryness)
Description	Worst postbaseline tolerability assessments for dryness.
Time Frame	Day 1 - Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	34 46.6%	28 NaN
Mild	35 47.9%	41 NaN
Moderate	4 5.5%	4 NaN
Severe	0 0%	0 NaN

8. Secondary Outcome

Title	Tolerability at Day 22 (Scaling)
Description	Tolerability assessments at day 22 for scaling
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	54 74%	48 NaN
Mild	12 16.4%	20 NaN
Moderate	3 4.1%	1 NaN
Severe	0 0%	0 NaN
Data Missing	4 5.5%	4 NaN

9. Primary Outcome

Title	Worst Postbaseline Tolerability (Stinging/Burning)
Description	Worst postbaseline tolerability assessments for stinging/burning
Time Frame	Day 1 - Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	51 69.9%	57 NaN
Mild	18 24.7%	14 NaN
Moderate	3 4.1%	2 NaN
Severe	1 1.4%	0 NaN

10. Secondary Outcome

Title	Tolerability at Day 22 (Stinging/Burning)
Description	Tolerability assessments at day 22 for stinging/burning
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
None	69 94.5%	69 NaN
Mild	0 0%	0 NaN
Moderate	0 0%	0 NaN
Severe	0 0%	0 NaN
Data Missing	4 5.5%	4 NaN

11. Secondary Outcome

Title	Cumulative Tolerability (Erythema)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
1	26	26
2	56	52
3	86	79
4	122	111
5	164	149
8	207	187
9	244	218
10	287	250
11	323	286
12	370	334
15	410	368
16	447	400
17	483	433
18	517	464
19	550	495
22	583	529

12. Secondary Outcome

Title	Cumulative Tolerability (Scaling)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
1	1	0
2	1	0
3	5	3
4	11	9
5	21	26
8	44	44
9	71	71
10	108	108
11	141	144
12	182	190
15	211	221
16	228	240
17	246	260
18	259	282
19	277	303
22	295	325

13. Secondary Outcome

Title	Cumulative Tolerability (Dryness)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
1	2	1
2	3	2
3	6	2
4	11	4
5	18	6
8	30	11
9	48	22
10	73	49
11	99	76
12	128	107
15	152	134
16	178	162
17	205	188
18	231	215
19	256	242
22	281	271

14. Secondary Outcome

Title	Cumulative Tolerability (Stinging/Burning)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
1	0	0
2	0	1
3	1	2
4	4	3
5	9	6
8	17	8
9	29	13
10	42	20
11	50	25
12	60	32
15	61	33
16	61	33
17	61	33
18	61	33
19	61	33
22	61	33

15. Secondary Outcome

Title	Cumulative Tolerability (Combined)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
1	29	27
2	60	55
3	98	86
4	148	127
5	212	187
8	298	250
9	392	324
10	510	427
11	613	531
12	740	663
15	834	756
16	914	835
17	995	914
18	1068	994
19	1144	1073
22	1220	1158

16. Other Pre-specified Outcome

Title	Overall Tolerability Preference Survey
Description	Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Epiduo Gel	Retin-A Micro Microsphere 0.1%
Arm/Group Description	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.	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.
Measure Participants	73	73
____ spread easier (n=71)	49 67.1%	22 NaN
____ absorbed quicker into my skin (n=71)	45 61.6%	26 NaN
____ had a more pleasant smell (n=71)	39 53.4%	32 NaN
____ felt better on my skin (n=71)	37 50.7%	34 NaN
____ left smaller amount of residue on skin (n=71)	50 68.5%	21 NaN
Overall, I prefer ____ (n=71)	44 60.3%	27 NaN

17. Post-Hoc Outcome

Title	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)
Description	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

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Epiduo Gel (Fitzpatrick Skin Types I-III)	Retin-A Micro (Fitzpatrick Skin Types I-III)	Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Retin-A Micro (Fitzpatrick Skin Types IV-VI)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	32	32
None	5 6.8%	7 NaN	20 NaN	21 NaN
Mild	18 24.7%	17 NaN	9 NaN	7 NaN
Moderate	16 21.9%	15 NaN	3 NaN	4 NaN
Severe	2 2.7%	2 NaN	0 NaN	0 NaN

18. Post-Hoc Outcome

Title	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)
Description	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

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Epiduo Gel (Fitzpatrick Skin Types I-III)	Retin-A Micro (Fitzpatrick Skin Types I-III)	Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Retin-A Micro (Fitzpatrick Skin Types IV-VI)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	32	32
None	13 17.8%	10 NaN	12 NaN	8 NaN
Mild	19 26%	22 NaN	15 NaN	21 NaN
Moderate	9 12.3%	9 NaN	5 NaN	3 NaN

19. Post-Hoc Outcome

Title	Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)
Description	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

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Epiduo Gel (Fitzpatrick Skin Types I-III)	Retin-A Micro (Fitzpatrick Skin Types I-III)	Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Retin-A Micro (Fitzpatrick Skin Types IV-VI)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	32	32
None	13 17.8%	14 NaN	21 NaN	14 NaN
Mild	26 35.6%	25 NaN	9 NaN	16 NaN
Moderate	2 2.7%	2 NaN	2 NaN	2 NaN

20. Post-Hoc Outcome

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

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Epiduo Gel (Fitzpatrick Skin Types I-III)	Retin-A Micro (Fitzpatrick Skin Types I-III)	Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Retin-A Micro (Fitzpatrick Skin Types IV-VI)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	32	32
None	28 38.4%	29 NaN	23 NaN	28 NaN
Mild	9 12.3%	10 NaN	9 NaN	4 NaN
Moderate	3 4.1%	2 NaN	0 NaN	0 NaN
Severe	1 1.4%	0 NaN	0 NaN	0 NaN

21. Post-Hoc Outcome

Title	Fitzpatrick Skin Type User Preference Survey at Day 22
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epiduo Gel (Fitzpatrick Skin Types I-III)	Retin-A Micro (Fitzpatrick Skin Types I-III)	Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Retin-A Micro (Fitzpatrick Skin Types IV-VI)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	39	39	32	32
Spread more easily	22 30.1%	17 NaN	27 NaN	5 NaN
Absorbed more quickly	22 30.1%	17 NaN	23 NaN	9 NaN
Smelled better	20 27.4%	19 NaN	19 NaN	13 NaN
Felt better	15 20.5%	24 NaN	22 NaN	10 NaN
Left less residue	25 34.2%	14 NaN	25 NaN	7 NaN
Overall	20 27.4%	19 NaN	24 NaN	8 NaN

22. Post-Hoc Outcome

Title	Fitzpatrick Skin Type Overall Tolerability Preference Survey Results
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epiduo Gel (Fitzpatrick Skin Types I-III)	Retin-A Micro (Fitzpatrick Skin Types I-III)	Epiduo Gel (Fitzpatrick Skin Types IV-VI)	Retin-A Micro (Fitzpatrick Skin Types IV-VI)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	40	40	32	32
Overall tolerability preference-investigator	21 28.8%	19 NaN	20 NaN	12 NaN
Overall tolerability preference - subject	21 28.8%	19 NaN	18 NaN	14 NaN

Adverse Events

Time Frame	Day 1 - Day 22
Arm/Group Title	Epiduo Gel		Retin-A Micro Microsphere 0.1%		Non-application Site
Arm/Group Description	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.		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.		Adverse events occurring on non-application sites
All Cause Mortality
	Epiduo Gel		Retin-A Micro Microsphere 0.1%		Non-application Site
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Epiduo Gel		Retin-A Micro Microsphere 0.1%		Non-application Site
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/73 (0%)		1/73 (1.4%)
Nervous system disorders
Epilepsy	0/73 (0%)	0	0/73 (0%)	0	1/73 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Epiduo Gel		Retin-A Micro Microsphere 0.1%		Non-application Site
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/73 (21.9%)		16/73 (21.9%)		0/73 (0%)
Skin and subcutaneous tissue disorders
Dry Skin	14/73 (19.2%)	14	15/73 (20.5%)	15	0/73 (0%)	0
Skin Burning Sensation	4/73 (5.5%)	4	2/73 (2.7%)	2	0/73 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.