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Trial record 90 of 339 for:    acne AND facial

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

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ClinicalTrials.gov Identifier: NCT01522456
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : August 18, 2015
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Epiduo Gel
Drug: Retin-A Micro Microsphere 0.1%
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Total Participants
Hide 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
Reason Not Completed
Adverse Event             2
Lost to Follow-up             2
Withdrawal by Subject             2
Pregnancy             1
Tolerability Assessment             1
Arm/Group Title Total Participants
Hide 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 Number of Baseline Participants 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants
30.8  (9.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
Female
53
  72.6%
Male
20
  27.4%
1.Primary Outcome
Title Worst Postbaseline Tolerability (Erythema)
Hide Description Worst postbaseline tolerability assessment for erythema.
Time Frame Day 1 - Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 25 28
Mild 27 24
Moderate 19 19
Severe 2 2
2.Primary Outcome
Title Worst Postbaseline Tolerability (Scaling)
Hide Description Worst postbaseline assessment for scaling.
Time Frame Day 1 - Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 25 18
Mild 34 43
Moderate 14 12
Severe 0 0
3.Primary Outcome
Title Worst Postbaseline Tolerability (Dryness)
Hide Description Worst postbaseline tolerability assessments for dryness.
Time Frame Day 1 - Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 34 28
Mild 35 41
Moderate 4 4
Severe 0 0
4.Primary Outcome
Title Worst Postbaseline Tolerability (Stinging/Burning)
Hide Description Worst postbaseline tolerability assessments for stinging/burning
Time Frame Day 1 - Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 51 57
Mild 18 14
Moderate 3 2
Severe 1 0
5.Secondary Outcome
Title Tolerability at Day 22 (Erythema)
Hide Description Tolerability assessments at day 22 for erythema
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 36 38
Mild 33 28
Moderate 0 3
Severe 0 0
Data Missing 4 4
6.Secondary Outcome
Title Tolerability at Day 22 (Dryness)
Hide Description Tolerability assessments at day 22 for dryness
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 44 40
Mild 25 29
Moderate 0 0
Severe 0 0
Data Missing 4 4
7.Secondary Outcome
Title Tolerability at Day 22 (Scaling)
Hide Description Tolerability assessments at day 22 for scaling
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 54 48
Mild 12 20
Moderate 3 1
Severe 0 0
Data Missing 4 4
8.Secondary Outcome
Title Tolerability at Day 22 (Stinging/Burning)
Hide Description Tolerability assessments at day 22 for stinging/burning
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
None 69 69
Mild 0 0
Moderate 0 0
Severe 0 0
Data Missing 4 4
9.Secondary Outcome
Title Cumulative Tolerability (Erythema)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: scores on a scale
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
10.Secondary Outcome
Title Cumulative Tolerability (Scaling)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: scores on a scale
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
11.Secondary Outcome
Title Cumulative Tolerability (Dryness)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: scores on a scale
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
12.Secondary Outcome
Title Cumulative Tolerability (Stinging/Burning)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: scores on a scale
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
13.Secondary Outcome
Title Cumulative Tolerability (Combined)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: scores on a scale
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
14.Other Pre-specified Outcome
Title User Preference Survey (Investigator)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
Day 5 (n=69) 34 35
Day 12 (n=67) 34 33
Day 19 (n=65) 37 28
Day 22 (n=72) 41 31
15.Other Pre-specified Outcome
Title User Preference Survey (Subjects)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
Day 5 (n=69) 42 27
Day 12 (n=67) 33 34
Day 19 (n=65) 36 29
Day 22 (n=72) 39 33
16.Other Pre-specified Outcome
Title Overall Tolerability Preference Survey
Hide Description Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1%
Hide 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.

Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
____ spread easier (n=71) 49 22
____ absorbed quicker into my skin (n=71) 45 26
____ had a more pleasant smell (n=71) 39 32
____ felt better on my skin (n=71) 37 34
____ left smaller amount of residue on skin (n=71) 50 21
Overall, I prefer ____ (n=71) 44 27
17.Post-Hoc Outcome
Title Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.

Overall Number of Participants Analyzed 41 41 32 32
Measure Type: Number
Unit of Measure: participants
None 5 7 20 21
Mild 18 17 9 7
Moderate 16 15 3 4
Severe 2 2 0 0
18.Post-Hoc Outcome
Title Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.

Overall Number of Participants Analyzed 41 41 32 32
Measure Type: Number
Unit of Measure: participants
None 13 10 12 8
Mild 19 22 15 21
Moderate 9 9 5 3
19.Post-Hoc Outcome
Title Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.

Overall Number of Participants Analyzed 41 41 32 32
Measure Type: Number
Unit of Measure: participants
None 13 14 21 14
Mild 26 25 9 16
Moderate 2 2 2 2
20.Post-Hoc Outcome
Title Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.

Overall Number of Participants Analyzed 41 41 32 32
Measure Type: Number
Unit of Measure: participants
None 28 29 23 28
Mild 9 10 9 4
Moderate 3 2 0 0
Severe 1 0 0 0
21.Post-Hoc Outcome
Title Fitzpatrick Skin Type User Preference Survey at Day 22
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.

Overall Number of Participants Analyzed 39 39 32 32
Measure Type: Number
Unit of Measure: participants
Spread more easily 22 17 27 5
Absorbed more quickly 22 17 23 9
Smelled better 20 19 19 13
Felt better 15 24 22 10
Left less residue 25 14 25 7
Overall 20 19 24 8
22.Post-Hoc Outcome
Title Fitzpatrick Skin Type Overall Tolerability Preference Survey Results
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.

Overall Number of Participants Analyzed 40 40 32 32
Measure Type: Number
Unit of Measure: participants
Overall tolerability preference-investigator 21 19 20 12
Overall tolerability preference - subject 21 19 18 14
Time Frame Day 1 - Day 22
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epiduo Gel Retin-A Micro Microsphere 0.1% Non-application Site
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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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide 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 (0.00%)      0/73 (0.00%)      1/73 (1.37%)    
Nervous system disorders       
Epilepsy * 1 [1]  0/73 (0.00%)  0 0/73 (0.00%)  0 1/73 (1.37%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
Epileptic seizure not related to study medicines.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (21.92%)      16/73 (21.92%)      0/73 (0.00%)    
Skin and subcutaneous tissue disorders       
Dry Skin * 1  14/73 (19.18%)  14 15/73 (20.55%)  15 0/73 (0.00%)  0
Skin Burning Sensation * 1  4/73 (5.48%)  4 2/73 (2.74%)  2 0/73 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth M. Nieman, Associate Medical Information Specialist
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5130
EMail: elizabeth.nieman@galderma.com
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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01522456     History of Changes
Other Study ID Numbers: US10201
First Submitted: January 23, 2012
First Posted: January 31, 2012
Results First Submitted: March 11, 2013
Results First Posted: August 18, 2015
Last Update Posted: August 18, 2015