Clinical trial NCT01522456: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Worst Postbaseline Tolerability (Erythema)
timeFrame: Day 1 - Day 22
measure: Worst Postbaseline Tolerability (Scaling)
timeFrame: Day 1 - Day 22
measure: Worst Postbaseline Tolerability (Dryness)
timeFrame: Day 1 - Day 22
measure: Worst Postbaseline Tolerability (Stinging/Burning)
timeFrame: Day 1 - Day 22
Secondary outcomes:
measure: Tolerability at Day 22 (Erythema)
timeFrame: Day 22
measure: Tolerability at Day 22 (Dryness)
timeFrame: Day 22
measure: Tolerability at Day 22 (Scaling)
timeFrame: Day 22
measure: Tolerability at Day 22 (Stinging/Burning)
timeFrame: Day 22
measure: Cumulative Tolerability (Erythema)
timeFrame: Day 1 - Day 22
measure: Cumulative Tolerability (Scaling)
timeFrame: Day 1 - Day 22
measure: Cumulative Tolerability (Dryness)
timeFrame: Day 1 - Day 22
measure: Cumulative Tolerability (Stinging/Burning)
timeFrame: Day 1 - Day 22
measure: Cumulative Tolerability (Combined)
timeFrame: Day 1 - Day 22
Other outcomes:
measure: User Preference Survey (Investigator)
timeFrame: Day 5, day 12, day 19, and day 22
measure: User Preference Survey (Subjects)
timeFrame: Day 5, day 12, day 19, and day 22
measure: Overall Tolerability Preference Survey
timeFrame: Day 22
Locations:
city: Dallas
country: United States
facility: Stephens and Associates
state: Texas
Study officials:
affiliation: Galderma R&D
name: Ronald Gottschalk, MD
role: STUDY_DIRECTOR
References: