Acne Vulgaris Clinical Trial
Official title:
Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Topical Antibiotic and Benzoyl Peroxide to Benzoyl Peroxide and Adapalene Topical Gel Acne Medications
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study
being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the
2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene
and the contra lateral side of the face will remain non-treated to serve as a control.
Approximately 25-30 male and female healthy subjects will be randomly assigned to each
product.
The subjects will be entered into a 2-week treatment phase. The once-daily applications for
the study medication will be supervised at the site, Monday through Friday of each week.
Subjects will apply the study product at home on Saturdays and Sundays.
A blinded expert grader will rate comparative product tolerance on each week day (excluding
Saturdays and Sundays) during the study before study product is applied.
Subject questionnaires will be completed along with collection of all adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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