Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Once-daily applications of clindamycin/BPO gel to the randomized side of the face either left or right. arm 2: Twice-daily applications of dapsone gel to one side of the face.

Interventions: intervention 1: clindamycin and benzoyl peroxide intervention 2: Dapsone gel
Intervention descriptions: intervention 1: Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide intervention 2: Twice-daily applications of dapsone gel

Protocol document: