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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Duac Gel (Drug); Differin gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire

Secondary outcome:

Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire

Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts

Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts

Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2

Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)

Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)

Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System

Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness

Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning

Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination

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.

Eligibility

Minimum age: 12 Years. Maximum age: 39 Years. Gender(s): Both.

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 and Contacts

Hospital Germans Trias I Pujol, Badalona 08916, Spain

Hospital del Mar, Barcelona 08003, Spain

Hospital Abente y Lago in La Coruna, La Coruna, Spain

Hospital Universitario 12 de Octubre, Madrid 28041, Spain

Hospital Universitario Ramón and Cajal, Madrid 28034, Spain

Hospital Clínico Universitario Ntra. Sra. de the Victoria, Málaga 29010, Spain

Clínica Universitaria de Navarra, Pamplona 31008, Spain

Hospital Clínico de Salamanca, Salamanca 37007, Spain

Additional Information

Starting date: November 2006
Last updated: March 15, 2012

Page last updated: August 20, 2015

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