NCT00964366

Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications

Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Clindamycin and Benzoyl Peroxide to Dapsone Gel Topical Acne Medications

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	clindamycin and benzoyl peroxide	Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide
DRUG	Dapsone gel	Twice-daily applications of dapsone gel

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-08-24
• Last updated: 2017-05-30
• Results posted: 2012-04-03

Locations

1 site across 1 country: United States