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

Stiefel

Status and phase

Completed

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Duac Gel

Drug: Differin gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00807014

S194-SP-05/Duac

114567

Details and patient eligibility

About

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.

Full 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.

Enrollment

169 patients

Sex

All

Ages

12 to 39 years old

Volunteers

No Healthy Volunteers

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.