Status:
COMPLETED
A Long Term Study of GK530G in Subjects With Acne Vulgaris
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT01910064
Start Date
May 1 2013
End Date
August 1 2014
Last Update
March 28 2017
Active Locations (16)
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1
Galderma investigational site
Urayasu, Chiba, Japan
2
Galderma investigational site
Fukuoka, Fukuoka, Japan
3
Galderma investigational site
Kawasaki, Kanagawa, Japan
4
Galderma investigational site
Yamato, Kanagawa, Japan