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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GK530G

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

Group Type EXPERIMENTAL

GK530G

Intervention Type DRUG

CD0271

Adapalene 01% Gel

Group Type ACTIVE_COMPARATOR

CD0271

Intervention Type DRUG

CD1579

Benzoyl Peroxide 2.5% Gel

Group Type ACTIVE_COMPARATOR

CD1579

Intervention Type DRUG

Interventions

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GK530G

Intervention Type DRUG

CD0271

Intervention Type DRUG

CD1579

Intervention Type DRUG

Other Intervention Names

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Fixed-dose combination gel of Adapalene and Benzoyl Peroxide Adapalene 0.1% Gel Benzoyl Peroxide 2.5% Gel

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No