This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,617
5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks
Differin 0.1% Gel, applied nightly for 12 weeks
Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks
Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Percentage Change From Baseline in Total Lesion Counts
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Time frame: Week 12
Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline
Time frame: Week 12
Percentage change from baseline in inflammatory lesion counts
Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.
Time frame: Week 12
Percentage change from baseline in non-inflammatory lesion counts
Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.
Time frame: Week 12
Change from baseline in inflammatory lesion counts
Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.
Time frame: Week 12
Change from baseline in non-inflammatory lesion counts
Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Time frame: Week 12
Change from baseline in total lesion counts
Absolute change from baseline in total lesions counts in each treatment group at Week 12.
Time frame: Week 12
Change from baseline in Investigator's Global Assessment (IGA)
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Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.
Time frame: Week 12
Treatment success rate
The proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)"; if IGA score at baseline is 2, success is only achieved if IGA score is 0 at Week 12.
Time frame: Week 12