Clinical trial NCT00807014: Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Differin
quality of life
Acne
Duac
Acne Vulgaris
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-12-11
Enrollment: 169
Sex: ALL
Minimum age (years): 12
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire
timeFrame: Baseline (Week 0) and Week 2
Secondary outcomes:
measure: Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire
timeFrame: Baseline (Week 0) and Week 12
measure: Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts
timeFrame: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12
measure: Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts
timeFrame: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12
measure: Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2
timeFrame: Baseline (Week 0) and Week 2
measure: 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)
timeFrame: Start of treatment and Weeks 1, 2, 4, 8, and 12
measure: 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)
timeFrame: Start of treatment and Weeks 1, 2, 4, 8, and 12
measure: Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System
timeFrame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness
timeFrame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning
timeFrame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12
measure: Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination
timeFrame: Week 12 or Early Termination
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: La Coruna
country: Spain
facility: Hospital Abente y Lago in La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario Ramón and Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Ntra. Sra. de the Victoria
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: