Last updated: 11/03/2018 16:50:33
Evaluation of quality of life, efficacy, and tolerance of Duac® gel compared to Differin® gel in the treatment of acne
GSK study ID
114567
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
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:
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
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
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
Correlation between Skindex-29 questionnaire scores and total lesion counts from Baseline to Week 2
Timeframe: Baseline (Week 0) and 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)
Timeframe: Start of treatment and Weeks 1, 2, 4, 8, and 12
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
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
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
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
Number of participants in the indicated categories for overall tolerance at Week 12/Early Termination
Timeframe: Week 12 or Early Termination
Interventions:
Drug: Duac Gel
Drug: Differin gel
Enrollment:
169
Observational study model:
Not applicable
Primary completion date:
2008-20-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate
Collaborators
GSK
Study date(s)
November 2006 to August 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12 - 39 years
Accepts healthy volunteers
No
- Subjects with mild to moderate acne vulgaris on the face,.
- Subjects of either sex aged between 12 and 39 years, inclusive.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
Hospital Clínico Universitario Ntra. Sra. de the Victoria
Málaga, Spain, 29010
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-20-08
Actual study completion date
2008-20-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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