NCT00926367

Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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, 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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clindamycin and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.
DRUG	benzoyl peroxide 2.5% and adapalene 0.1% gel	Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2009-06-23
• Last updated: 2015-05-20
• Results posted: 2011-08-04

Locations

1 site across 1 country: United States