This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
417
Galderma investigational site
Chitose, Hokkaido, Japan
Galderma investigational site
Kitami, Hokkaido, Japan
Galderma investigational site
Sapporo, Hokkaido, Japan
Percent Changes From Baseline in Total Lesion Counts
Time frame: Baseline - Week12
Percent of Subjects With Adverse Events
Time frame: up to 12 weeks
Local Tolerability (Erythema)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
Local Tolerability (Scaling)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
Local Tolerability (Dryness)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
Local Tolerability (Pruritus)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
Local Tolerability (Stinging/Burning)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
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Galderma investigational site
Kagoshima, Kagoshima-ken, Japan
Galderma investigational site
Yokohama, Kanagawa, Japan
Galderma investigational site
Kurashiki, Okayama-ken, Japan
Galderma investigational site
Daitō, Osaka, Japan
Galderma investigational site
Neyagawa, Osaka, Japan
Galderma investigational site
Osaka, Osaka, Japan
Galderma investigational site
Sakai, Osaka, Japan
...and 3 more locations