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
• 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

• Acne Vulgaris

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