Back to resultsA Long Term Study of GK530G in Subjects With Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GK530G
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris
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
Sites / Locations
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GK530G
Arm Description
GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
Outcomes
Primary Outcome Measures
Local Tolerability (Erythema)
Highest severity of Local tolerability scores worth than base line
Local Tolerability (Scaling)
Highest severity of Local tolerability scores worth than base line
Local Tolerability (Dryness)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Local Tolerability (Pruritus)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Local Tolerability (Stinging/Burning)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Secondary Outcome Measures
Percent Changes From Baseline in Total Lesion Counts
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01910064
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
436 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GK530G
Arm Type
Experimental
Arm Description
GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
Intervention Type
Drug
Intervention Name(s)
GK530G
Other Intervention Name(s)
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Primary Outcome Measure Information:
Title
Local Tolerability (Erythema)
Description
Highest severity of Local tolerability scores worth than base line
Time Frame
12 monhths
Title
Local Tolerability (Scaling)
Description
Highest severity of Local tolerability scores worth than base line
Time Frame
12 months
Title
Local Tolerability (Dryness)
Description
Highest Severity of Local Tolerability Scores Worse Than Baseline
Time Frame
12 months
Title
Local Tolerability (Pruritus)
Description
Highest Severity of Local Tolerability Scores Worse Than Baseline
Time Frame
12 months
Title
Local Tolerability (Stinging/Burning)
Description
Highest Severity of Local Tolerability Scores Worse Than Baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percent Changes From Baseline in Total Lesion Counts
Time Frame
Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Galderma investigational site
City
Urayasu
State/Province
Chiba
Country
Japan
Facility Name
Galderma investigational site
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Galderma investigational site
City
Yamato
State/Province
Kanagawa
Country
Japan
Facility Name
Galderma investigational site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Galderma investigational site
City
Kumagaya
State/Province
Saitama
Country
Japan
Facility Name
Galderma investigational site
City
Chiyoda
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Koto
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Machida
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Musashino
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Ota
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Shibuya
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Suginami
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Tachikawa
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Koto
State/Province
Tpkyo
Country
Japan
Facility Name
Galderma investigational site
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Long Term Study of GK530G in Subjects With Acne Vulgaris
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