NCT00807014

Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne

Single-blind, Multicenter, Parallel, Comparative, Randomized, Phase 4 Clinical Trial for the Evaluation of the Quality of Life, Efficacy and Tolerance of Duac® Gel Against Differin® Gel in the Topical Treatment of Mild to Moderate Acne Vulgaris.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 12 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.

Detailed description

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial. Acne vulgaris is the most common dermatological disorder. It affects approximately 85% individuals at some point in their lives, generally between 12 and 24 years of age. Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant. There are several medicinal products used to treat acne. However, the therapeutic challenge remains, therefore it is essential to continue investigating effective strategies for the treatment of this disease.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Duac Gel	Duac® Gel will be applied to the face once daily at night, for 12 weeks.
DRUG	Differin gel	Differin Gel will be applied to the face once daily at night, for 12 weeks.

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-12-11
• Last updated: 2012-03-20
• Results posted: 2012-03-06

Locations

8 sites across 1 country: Spain