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

February 27, 2017 updated by: Galderma R&D

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima, Japan
        • Galderma Investigational Site
      • Osaka, Japan
        • Galderma Investigational Site
      • Saitama, Japan
        • Galderma Investigational Site
    • Hokkaido
      • Chitose, Hokkaido, Japan
        • Galderma Investigational Site
      • Kitami, Hokkaido, Japan
        • Galderma Investigational Site
      • Sapporo, Hokkaido, Japan
        • Galderma Investigational Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan
        • Galderma Investigational Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Galderma Investigational Site
    • Osaka
      • Daito, Osaka, Japan
        • Galderma Investigational Site
      • Neyagawa, Osaka, Japan
        • Galderma Investigational Site
      • Sakai, Osaka, Japan
        • Galderma Investigational Site
    • Tokyo
      • Adachi, Tokyo, Japan
        • Galderma Investigational Site
      • Setagaya, Tokyo, Japan
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GK530G
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Drug: GK530G
Other Names:
  • Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Active Comparator: CD0271
Adapalene 01% Gel
Drug: CD0271
Other Names:
  • Adapalene 0.1% Gel
Active Comparator: CD1579
Benzoyl Peroxide 2.5% Gel
Drug: CD1579
Other Names:
  • Benzoyl Peroxide 2.5% Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Changes From Baseline in Total Lesion Counts
Time Frame: Baseline - Week12
Baseline - Week12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDT.07.SPR.27123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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