A Long Term Study of GK530G in Subjects With Acne Vulgaris

February 27, 2017 updated by: Galderma R&D
This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

436

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
      • Fukuoka, Japan
        • Galderma Investigational Site
    • Chiba
      • Urayasu, Chiba, Japan
        • Galderma Investigational Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • Galderma Investigational Site
      • Yamato, Kanagawa, Japan
        • Galderma Investigational Site
      • Yokohama, Kanagawa, Japan
        • Galderma Investigational Site
    • Saitama
      • Kumagaya, Saitama, Japan
        • Galderma Investigational Site
    • Tokyo
      • Chiyoda, Tokyo, Japan
        • Galderma Investigational Site
      • Koto, Tokyo, Japan
        • Galderma Investigational Site
      • Machida, Tokyo, Japan
        • Galderma Investigational Site
      • Musashino, Tokyo, Japan
        • Galderma Investigational Site
      • Ota, Tokyo, Japan
        • Galderma Investigational Site
      • Shibuya, Tokyo, Japan
        • Galderma Investigational Site
      • Shinjuku, Tokyo, Japan
        • Galderma Investigational Site
      • Suginami, Tokyo, Japan
        • Galderma Investigational Site
      • Tachikawa, Tokyo, Japan
        • Galderma Investigational Site
    • Tpkyo
      • Koto, Tpkyo, 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 (ADULT, OLDER_ADULT, CHILD)

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 non-inflammatory 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 cyst.
  • 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GK530G
GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
Drug: GK530G
Other Names:
  • Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Tolerability (Erythema)
Time Frame: 12 monhths
Highest severity of Local tolerability scores worth than base line
12 monhths
Local Tolerability (Scaling)
Time Frame: 12 months
Highest severity of Local tolerability scores worth than base line
12 months
Local Tolerability (Dryness)
Time Frame: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
12 months
Local Tolerability (Pruritus)
Time Frame: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
12 months
Local Tolerability (Stinging/Burning)
Time Frame: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Changes From Baseline in Total Lesion Counts
Time Frame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12
Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12

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

May 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (ESTIMATE)

July 29, 2013

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.27125

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.

Clinical Trials on Acne Vulgaris

Clinical Trials on GK530G

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe