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

CompletedPhase 4

Sponsor: Stiefel, a GSK Company

Conditions: Acne Vulgaris

Interventions: Duac Gel, Differin gel

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 39 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Subjects with mild to moderate acne vulgaris on the face,.
* Subjects of either sex aged between 12 and 39 years, inclusive.
* Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view
* Subjects using anti-androgen containing contraceptives.
* Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy.
* Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study.
* Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator.
* Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
* Subjects with a history of photosensitivity.

Locations (8)

A Coruña, Spain
Badalona, Spain
Barcelona, Spain
Madrid, Spain
Madrid, Spain
Málaga, Spain
Pamplona, Spain
Salamanca, Spain