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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
73
Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.
Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Stephens and Associates
Dallas, Texas, United States
Worst Postbaseline Tolerability (Erythema)
Worst postbaseline tolerability assessment for erythema.
Time frame: Day 1 - Day 22
Worst Postbaseline Tolerability (Scaling)
Worst postbaseline assessment for scaling.
Time frame: Day 1 - Day 22
Worst Postbaseline Tolerability (Dryness)
Worst postbaseline tolerability assessments for dryness.
Time frame: Day 1 - Day 22
Worst Postbaseline Tolerability (Stinging/Burning)
Worst postbaseline tolerability assessments for stinging/burning
Time frame: Day 1 - Day 22
Tolerability at Day 22 (Erythema)
Tolerability assessments at day 22 for erythema
Time frame: Day 22
Tolerability at Day 22 (Dryness)
Tolerability assessments at day 22 for dryness
Time frame: Day 22
Tolerability at Day 22 (Scaling)
Tolerability assessments at day 22 for scaling
Time frame: Day 22
Tolerability at Day 22 (Stinging/Burning)
Tolerability assessments at day 22 for stinging/burning
Time frame: Day 22
Cumulative Tolerability (Erythema)
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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
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
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
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
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