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 QuestionnaireMean 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 ClÃnico Universitario Ntra. Sra. de the Victoria, Málaga 29010, Spain
ClÃnica Universitaria de Navarra, Pamplona 31008, Spain
Hospital ClÃnico de Salamanca, Salamanca 37007, Spain
Additional Information
Starting date: November 2006
Last updated: March 15, 2012
|