Acne Vulgaris Clinical Trial
Official title:
Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Clindamycin and Benzoyl Peroxide to Dapsone Gel Topical Acne Medications
This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control.
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, clindamycin and benzoyl peroxide or dapsone 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 without facial acne, aged 18 to 45, will be randomly assigned to
each product.
The eligible subjects who qualify will be entered into a 2-week treatment phase. The first
of application of the study medication will be supervised at the site, Monday through Friday
of each week. Any additional applications should be applied by the subjects at home each
evening and the times of application recorded on a diary card. Subjects will apply the study
product at home on Saturdays and Sundays and record the times of application on a diary
card.
A blinded expert grader will rate comparative product tolerance during the study before
study product is applied.
Instrumentation measurements of TEWL will be utilized to evaluate product mildness.
Duplicate sebum samples will be taken from the left and right forehead areas and assessed.
Subject will complete questionnaires and all adverse events will be recorded.
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