Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Padagis LLC; Perrigo Company
• Treatments: Benzoyl Peroxide; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

Inclusion Criteria:

• healthy men or women, 12 years of age and older

• willing to participate and sign a copy of the informed consent form

• moderate to severe facial acne

Exclusion Criteria:

• history of allergy or hypersensitivity to clindamycin or benzoyl peroxide

• pregnant or lactating women

• evidence of a clinically significant disorder

• receipt of any drugs as part of a research study within 30 days prior to study dosing

• use of systemic, topical or facial products which may interfere with study

• significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn