Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: CD0271; Drug: CD1579; Drug: GK530G

Study type: Interventional

Funder types: Industry

Identifiers

NCT02073448

RDT.07.SPR.27123

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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417 participants in 3 patient groups

GK530G

Experimental group

Description:

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

Treatment:

Drug: GK530G

CD0271

Active Comparator group

Description:

Adapalene 01% Gel

Treatment:

Drug: CD0271

CD1579

Active Comparator group

Description:

Benzoyl Peroxide 2.5% Gel

Treatment:

Drug: CD1579