A Long Term Study of GK530G in Subjects With Acne Vulgaris

NCT ID: NCT01910064

Last Updated: 2017-03-28

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GK530G

GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO

Group Type EXPERIMENTAL

GK530G

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GK530G

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Galderma investigational site

Urayasu, Chiba, Japan

Site Status

Galderma investigational site

Fukuoka, Fukuoka, Japan

Site Status

Galderma investigational site

Kawasaki, Kanagawa, Japan

Site Status

Galderma investigational site

Yamato, Kanagawa, Japan

Site Status

Galderma investigational site

Yokohama, Kanagawa, Japan

Site Status

Galderma investigational site

Kumagaya, Saitama, Japan

Site Status

Galderma investigational site

Chiyoda City, Tokyo, Japan

Site Status

Galderma investigational site

Koto, Tokyo, Japan

Site Status

Galderma investigational site

Machida, Tokyo, Japan

Site Status

Galderma investigational site

Musashino, Tokyo, Japan

Site Status

Galderma investigational site

Ōta-ku, Tokyo, Japan

Site Status

Galderma investigational site

Shibuya City, Tokyo, Japan

Site Status

Galderma investigational site

Shinjuku, Tokyo, Japan

Site Status

Galderma investigational site

Suginami, Tokyo, Japan

Site Status

Galderma investigational site

Tachikawa, Tokyo, Japan

Site Status

Galderma investigational site

Kōtō City, Tpkyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RDT.07.SPR.27125

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.