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

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073448
• Other study ID #: RDT.07.SPR.27123
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2014
• Last updated: November 17, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• GK530G

• CD0271

• CD1579

Locations

Country	Name	City	State
Japan	Galderma investigational site	Adachi	Tokyo
Japan	Galderma investigational site	Chitose	Hokkaido
Japan	Galderma investigational site	Daito	Osaka
Japan	Galderma investigational site	Kagoshima
Japan	Galderma investigational site	Kitami	Hokkaido
Japan	Galderma investigational site	Kurashiki	Okayama
Japan	Galderma investigational site	Neyagawa	Osaka
Japan	Galderma investigational site	Osaka
Japan	Galderma investigational site	Saitama
Japan	Galderma investigational site	Sakai	Osaka
Japan	Galderma investigational site	Sapporo	Hokkaido
Japan	Galderma investigational site	Setagaya	Tokyo
Japan	Galderma investigational site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in total lesion counts		12 weeks	No
Secondary	Percent of Subjects With Adverse Events		up to 12 weeks	Yes