Clinical trial NCT02073448: Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
Official title: A Multicenter, Randomized, Double-blinded, Active-controlled Parallel Group Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 417
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Men and women at the age of 12 or older at the Screening visit.
* Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

* Those with more than two nodular acne lesions or any cysts.
* Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
* Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment.

Primary outcomes:
measure: Percent Changes From Baseline in Total Lesion Counts
timeFrame: Baseline - Week12
Secondary outcomes:
measure: Percent of Subjects With Adverse Events
timeFrame: up to 12 weeks
measure: Local Tolerability (Erythema)
timeFrame: 12 weeks
measure: Local Tolerability (Scaling)
timeFrame: 12 weeks
measure: Local Tolerability (Dryness)
timeFrame: 12 weeks
measure: Local Tolerability (Pruritus)
timeFrame: 12 weeks
measure: Local Tolerability (Stinging/Burning)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chitose
country: Japan
facility: Galderma investigational site
state: Hokkaido
city: Kitami
country: Japan
facility: Galderma investigational site
state: Hokkaido
city: Sapporo
country: Japan
facility: Galderma investigational site
state: Hokkaido
city: Yokohama
country: Japan
facility: Galderma investigational site
state: Kanagawa
city: Kurashiki
country: Japan
facility: Galderma investigational site
state: Okayama
city: Daito
country: Japan
facility: Galderma investigational site
state: Osaka
city: Neyagawa
country: Japan
facility: Galderma investigational site
state: Osaka
city: Sakai
country: Japan
facility: Galderma investigational site
state: Osaka
city: Adachi
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Setagaya
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Kagoshima
country: Japan
facility: Galderma investigational site
city: Osaka
country: Japan
facility: Galderma investigational site
city: Saitama
country: Japan
facility: Galderma investigational site
Study officials:
References: