Back to resultsSplit-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epiduo Gel
Retin-A Micro Microsphere 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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)
Sites / Locations
- Stephens and Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Epiduo Gel
Retin-A Micro Microsphere 0.1%
Arm Description
Adapalene 0.1% and benzoyl peroxide 2.5% gel
Tretinoin gel, 0.1%
Outcomes
Primary Outcome Measures
Worst Postbaseline Tolerability (Erythema)
Worst postbaseline tolerability assessment for erythema.
Worst Postbaseline Tolerability (Scaling)
Worst postbaseline assessment for scaling.
Worst Postbaseline Tolerability (Dryness)
Worst postbaseline tolerability assessments for dryness.
Worst Postbaseline Tolerability (Stinging/Burning)
Worst postbaseline tolerability assessments for stinging/burning
Secondary Outcome Measures
Tolerability at Day 22 (Erythema)
Tolerability assessments at day 22 for erythema
Tolerability at Day 22 (Dryness)
Tolerability assessments at day 22 for dryness
Tolerability at Day 22 (Scaling)
Tolerability assessments at day 22 for scaling
Tolerability at Day 22 (Stinging/Burning)
Tolerability assessments at day 22 for stinging/burning
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01522456
Brief Title
Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epiduo Gel
Arm Type
Active Comparator
Arm Description
Adapalene 0.1% and benzoyl peroxide 2.5% gel
Arm Title
Retin-A Micro Microsphere 0.1%
Arm Type
Active Comparator
Arm Description
Tretinoin gel, 0.1%
Intervention Type
Drug
Intervention Name(s)
Epiduo Gel
Intervention Description
Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.
Intervention Type
Drug
Intervention Name(s)
Retin-A Micro Microsphere 0.1%
Intervention Description
Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Primary Outcome Measure Information:
Title
Worst Postbaseline Tolerability (Erythema)
Description
Worst postbaseline tolerability assessment for erythema.
Time Frame
Day 1 - Day 22
Title
Worst Postbaseline Tolerability (Scaling)
Description
Worst postbaseline assessment for scaling.
Time Frame
Day 1 - Day 22
Title
Worst Postbaseline Tolerability (Dryness)
Description
Worst postbaseline tolerability assessments for dryness.
Time Frame
Day 1 - Day 22
Title
Worst Postbaseline Tolerability (Stinging/Burning)
Description
Worst postbaseline tolerability assessments for stinging/burning
Time Frame
Day 1 - Day 22
Secondary Outcome Measure Information:
Title
Tolerability at Day 22 (Erythema)
Description
Tolerability assessments at day 22 for erythema
Time Frame
Day 22
Title
Tolerability at Day 22 (Dryness)
Description
Tolerability assessments at day 22 for dryness
Time Frame
Day 22
Title
Tolerability at Day 22 (Scaling)
Description
Tolerability assessments at day 22 for scaling
Time Frame
Day 22
Title
Tolerability at Day 22 (Stinging/Burning)
Description
Tolerability assessments at day 22 for stinging/burning
Time Frame
Day 22
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
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
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
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
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
Other Pre-specified Outcome Measures:
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Stephens and Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
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