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NCT01910064 Clinical Trial

A Long Term Study of GK530G in Subjects With Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:
A Long Term Study of GK530G in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01910064
Other study ID # RDT.07.SPR.27125
Secondary ID
Status Completed
Phase Phase 3
First received July 25, 2013
Last updated September 4, 2014
Start date May 2013
Est. completion date August 2014

Study information
Verified date September 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 436
Est. completion date August 2014
Est. primary completion date August 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 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GK530G

Locations
Country Name City State
Japan Galderma investigational site Chiyoda Tokyo
Japan Galderma investigational site Fukuoka
Japan Galderma investigational site Kawasaki Kanagawa
Japan Galderma investigational site Koto Tpkyo
Japan Galderma investigational site Koto Tokyo
Japan Galderma investigational site Kumagaya Saitama
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 Urayasu Chiba
Japan Galderma investigational site Yamato Kanagawa
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 Safety criteria The safety evaluation consists of local tolerability assessment, physical examination, vital sign recording, laboratory tests (hematology, blood chemistries, and urinalysis), adverse events (AEs) recording. 12 monhths Yes
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