Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
Title: A Multi-Centre, Single-Blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Duac® Gel (a Gel Containing Clindamycin Phosphate \[Equivalent to 1% Clindamycin\] and 5% Benzoyl Peroxide) And Differin® Gel (a Gel Containing 0.1% Adapalene) in the Topical Treatment of Mild to Moderate Acne Vulgaris Objectives: To compare the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity. Study methodology: Randomised, comparator-controlled, single-blind trial. The Investigators/ Assessors will be blinded to the treatment received. Study population: Male and female patients, aged 12-39, with mild to moderate acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
130
Prof A Langner
Warsaw, Poland
Dr V Goulden
Leeds, United Kingdom
Dr A Chu
London, United Kingdom
Percentage change from baseline of inflammatory lesion counts at week 2
Absolute change from baseline of inflammatory lesion counts at week 2.
Absolute change and percentage change from baseline of inflammatory lesion counts at weeks 1, 4, 8 and 12.
Absolute change and percentage change from baseline of non-inflammatory lesion counts and total lesion counts at weeks 1, 2, 4, 8 and 12.
Also, acne grade and global change score at weeks 1, 2, 4, 8 and 12 will be investigated.
Patient's self-rating assessment at weeks 1, 2, 4, 8 and 12.
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