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

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: GK530G; Drug: CD0271; Drug: CD1579

• Registration Number: NCT02073448
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Study Start: 2014-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-09-15
• Results First Submitted QC: 2016-09-15
• Results First Posted: 2016-11-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GK530G	GK530G	Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
CD0271	CD0271	Adapalene 01% Gel
CD1579	CD1579	Benzoyl Peroxide 2.5% Gel

Primary Outcome Measures

Name	Time	Method
Percent Changes From Baseline in Total Lesion Counts	Baseline - Week12

Secondary Outcome Measures

Name	Time	Method
Percent of Subjects With Adverse Events	up to 12 weeks
Local Tolerability (Erythema)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Scaling)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Pruritus)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Stinging/Burning)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Dryness)	12 weeks	Highest severity of local tolerability scores worse than Baseline

Trial Locations

Locations (1)

Galderma investigational site; 🇯🇵 Saitama, Japan