NCT00757523

Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris

A Multi-center, Randomized, Evaluator-blind, Parallel-group Evaluation of the Efficacy, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Topical Treatment of Facial Acne Vulgaris

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris

Detailed description

Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Epiduo Gel	Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
DRUG	Duac Gel	Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks

Timeline

• Start date: 2008-09-10
• Primary completion: 2009-04-24
• Completion: 2009-06-24
• First posted: 2008-09-23
• Last updated: 2017-08-17

Locations

17 sites across 1 country: Germany