Acne Vulgaris
Conditions
Keywords
Acne Vulgaris
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.
Interventions
DRUGGK530G
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tolerability (Pruritus) | 12 months | Highest Severity of Local Tolerability Scores Worse Than Baseline |
| Local Tolerability (Erythema) | 12 monhths | Highest severity of Local tolerability scores worth than base line |
| Local Tolerability (Scaling) | 12 months | Highest severity of Local tolerability scores worth than base line |
| Local Tolerability (Dryness) | 12 months | Highest Severity of Local Tolerability Scores Worse Than Baseline |
| Local Tolerability (Stinging/Burning) | 12 months | Highest Severity of Local Tolerability Scores Worse Than Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Percent Changes From Baseline in Total Lesion Counts | Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12 |
Countries
Japan
Participant flow
Recruitment details
436 subjects have been enrolled in 20 site in Japan: First subject included: May 16, 2013; last subject out: July 18, 2014
Participants by arm
| Arm | Count |
|---|---|
| GK530G the fixed-dose combination gel of Adapalene and Benzoyl Peroxide | 436 |
| Total | 436 |
Baseline characteristics
| Characteristic | GK530G |
|---|---|
| Age, Continuous | 21.1 years STANDARD_DEVIATION 6.6 |
| Sex: Female, Male Female | 246 Participants |
| Sex: Female, Male Male | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 311 / 436 |
| serious Total, serious adverse events | 6 / 436 |
Outcome results
Primary
Local Tolerability (Dryness)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK530G | Local Tolerability (Dryness) | Mild | 254 participants |
| GK530G | Local Tolerability (Dryness) | Moderate | 52 participants |
| GK530G | Local Tolerability (Dryness) | Severe | 1 participants |
Primary
Local Tolerability (Erythema)
Highest severity of Local tolerability scores worth than base line
Time frame: 12 monhths
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK530G | Local Tolerability (Erythema) | Mild | 149 participants |
| GK530G | Local Tolerability (Erythema) | Moderate | 64 participants |
| GK530G | Local Tolerability (Erythema) | Severe | 5 participants |
Primary
Local Tolerability (Pruritus)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK530G | Local Tolerability (Pruritus) | Moderate | 35 participants |
| GK530G | Local Tolerability (Pruritus) | Mild | 149 participants |
| GK530G | Local Tolerability (Pruritus) | Severe | 4 participants |
Primary
Local Tolerability (Scaling)
Highest severity of Local tolerability scores worth than base line
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK530G | Local Tolerability (Scaling) | Mild | 191 participants |
| GK530G | Local Tolerability (Scaling) | Moderate | 60 participants |
| GK530G | Local Tolerability (Scaling) | Severe | 2 participants |
Primary
Local Tolerability (Stinging/Burning)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK530G | Local Tolerability (Stinging/Burning) | Mild | 251 subjects |
| GK530G | Local Tolerability (Stinging/Burning) | Moderate | 79 subjects |
| GK530G | Local Tolerability (Stinging/Burning) | Severe | 9 subjects |
Secondary
Percent Changes From Baseline in Total Lesion Counts
Time frame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Week 1 | 25.6 percent change |
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Week 2 | 42.1 percent change |
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Week 4 | 52.9 percent change |
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Month 2 | 67.1 percent change |
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Month 3 | 74.7 percent change |
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Month 6 | 82.0 percent change |
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Month 9 | 83.6 percent change |
| GK530G | Percent Changes From Baseline in Total Lesion Counts | Month 12 | 86.2 percent change |