Clinical trial NCT01910064: A Long Term Study of GK530G in Subjects With Acne Vulgaris
Official title: A Long Term Study of GK530G in Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 436
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 treatment.


Eligibility criteria: 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

Primary outcomes:
measure: Local Tolerability (Erythema)
timeFrame: 12 monhths
measure: Local Tolerability (Scaling)
timeFrame: 12 months
measure: Local Tolerability (Dryness)
timeFrame: 12 months
measure: Local Tolerability (Pruritus)
timeFrame: 12 months
measure: Local Tolerability (Stinging/Burning)
timeFrame: 12 months
Secondary outcomes:
measure: Percent Changes From Baseline in Total Lesion Counts
timeFrame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12
Other outcomes:
Locations:
city: Urayasu
country: Japan
facility: Galderma investigational site
state: Chiba
city: Kawasaki
country: Japan
facility: Galderma investigational site
state: Kanagawa
city: Yamato
country: Japan
facility: Galderma investigational site
state: Kanagawa
city: Yokohama
country: Japan
facility: Galderma investigational site
state: Kanagawa
city: Kumagaya
country: Japan
facility: Galderma investigational site
state: Saitama
city: Chiyoda
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Koto
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Machida
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Musashino
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Ota
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Shibuya
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Shinjuku
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Suginami
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Tachikawa
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Koto
country: Japan
facility: Galderma investigational site
state: Tpkyo
city: Fukuoka
country: Japan
facility: Galderma investigational site
Study officials:
References: