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

NCT ID: NCT00807014

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Duac Gel

Duac Gel

Group Type: EXPERIMENTAL

Duac Gel

Intervention Type: DRUG

Duac® Gel will be applied to the face once daily at night, for 12 weeks.

Differin gel

Differin gel

Group Type: ACTIVE_COMPARATOR

Differin gel

Intervention Type: DRUG

Differin Gel will be applied to the face once daily at night, for 12 weeks.

Interventions

Duac Gel

Duac® Gel will be applied to the face once daily at night, for 12 weeks.

Intervention Type: DRUG

Differin gel

Differin Gel will be applied to the face once daily at night, for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Duac; Differin

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Hospital Abente y Lago in La Coruna

A Coruña, , Spain

Hospital Germans Trias I Pujol

Badalona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario Ramón and Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Clínico Universitario Ntra. Sra. de the Victoria

Málaga, , Spain

Clínica Universitaria de Navarra

Pamplona, , Spain

Hospital Clínico de Salamanca

Salamanca, , Spain

Countries

Spain

Other Identifiers

S194-SP-05/Duac

Identifier Type: -

Identifier Source: secondary_id

114567

Identifier Type: -

Identifier Source: org_study_id