Acne Vulgaris
Conditions
Keywords
Acne Vulgaris
Brief summary
This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.
Interventions
DRUGCD1579 2.5%
DRUGCD1579 5%
DRUGVehicle
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 noninflammatory 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 cysts. * 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 |
|---|---|---|
| Percent Changes From Baseline in Total Lesion Counts | Baseline - Week 12 | Median percent reductions from Baseline in total lesion count (ITT-LOCF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Tolerability (Erythema) | 12 weeks | Highest severity of local tolerability scores worse than Baseline |
| Local Tolerability (Scaling) | 12 weeks | Highest severity of local tolerability scores worse than Baseline |
| Percent of Subjects With Adverse Events | up to 12 weeks | Adverse events which were observed in 5% or more patients with either group are listed. |
| Local Tolerability (Pruritus) | 12 weeks | Highest severity of local tolerability scores worse than Baseline |
| Local Tolerability (Stinging/Burning) | 12 weeks | Highest severity of local tolerability scores worse than Baseline |
| Local Tolerability (Dryness) | 12 weeks | Highest severity of local tolerability scores worse than Baseline |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD1579 2.5% Benzoyl Peroxide 2.5%
CD1579 2.5% | 79 |
| CD1579 5% Benzoyl Peroxide 5%
CD1579 5% | 78 |
| Vehicle Vehicle
Vehicle | 79 |
| Total | 236 |
Baseline characteristics
| Characteristic | CD1579 2.5% | CD1579 5% | Vehicle | Total |
|---|---|---|---|---|
| Age, Continuous | 22.1 years STANDARD_DEVIATION 7 | 21.1 years STANDARD_DEVIATION 5.6 | 21.0 years STANDARD_DEVIATION 6.3 | 21.4 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment Japan | 79 participants | 78 participants | 79 participants | 236 participants |
| Sex: Female, Male Female | 57 Participants | 51 Participants | 45 Participants | 153 Participants |
| Sex: Female, Male Male | 22 Participants | 27 Participants | 34 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 79 | 31 / 78 | 26 / 79 |
| serious Total, serious adverse events | 0 / 79 | 0 / 78 | 1 / 79 |
Outcome results
Primary
Percent Changes From Baseline in Total Lesion Counts
Median percent reductions from Baseline in total lesion count (ITT-LOCF)
Time frame: Baseline - Week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CD1579 2.5% | Percent Changes From Baseline in Total Lesion Counts | 58.3 percent change |
| CD1579 5% | Percent Changes From Baseline in Total Lesion Counts | 65.9 percent change |
| Vehicle | Percent Changes From Baseline in Total Lesion Counts | 25.5 percent change |
Secondary
Local Tolerability (Dryness)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD1579 2.5% | Local Tolerability (Dryness) | Mild | 20 participants |
| CD1579 2.5% | Local Tolerability (Dryness) | Moderate | 2 participants |
| CD1579 5% | Local Tolerability (Dryness) | Mild | 33 participants |
| CD1579 5% | Local Tolerability (Dryness) | Moderate | 6 participants |
| Vehicle | Local Tolerability (Dryness) | Mild | 10 participants |
| Vehicle | Local Tolerability (Dryness) | Moderate | 0 participants |
Secondary
Local Tolerability (Erythema)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD1579 2.5% | Local Tolerability (Erythema) | Moderate | 3 participants |
| CD1579 2.5% | Local Tolerability (Erythema) | Mild | 12 participants |
| CD1579 2.5% | Local Tolerability (Erythema) | Severe | 0 participants |
| CD1579 5% | Local Tolerability (Erythema) | Moderate | 3 participants |
| CD1579 5% | Local Tolerability (Erythema) | Mild | 18 participants |
| CD1579 5% | Local Tolerability (Erythema) | Severe | 1 participants |
| Vehicle | Local Tolerability (Erythema) | Mild | 5 participants |
| Vehicle | Local Tolerability (Erythema) | Severe | 0 participants |
| Vehicle | Local Tolerability (Erythema) | Moderate | 0 participants |
Secondary
Local Tolerability (Pruritus)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD1579 2.5% | Local Tolerability (Pruritus) | Moderate | 6 participants |
| CD1579 2.5% | Local Tolerability (Pruritus) | Mild | 20 participants |
| CD1579 2.5% | Local Tolerability (Pruritus) | Severe | 1 participants |
| CD1579 5% | Local Tolerability (Pruritus) | Moderate | 7 participants |
| CD1579 5% | Local Tolerability (Pruritus) | Mild | 13 participants |
| CD1579 5% | Local Tolerability (Pruritus) | Severe | 2 participants |
| Vehicle | Local Tolerability (Pruritus) | Mild | 6 participants |
| Vehicle | Local Tolerability (Pruritus) | Severe | 0 participants |
| Vehicle | Local Tolerability (Pruritus) | Moderate | 1 participants |
Secondary
Local Tolerability (Scaling)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD1579 2.5% | Local Tolerability (Scaling) | Mild | 15 participants |
| CD1579 2.5% | Local Tolerability (Scaling) | Moderate | 4 participants |
| CD1579 5% | Local Tolerability (Scaling) | Mild | 25 participants |
| CD1579 5% | Local Tolerability (Scaling) | Moderate | 7 participants |
| Vehicle | Local Tolerability (Scaling) | Mild | 8 participants |
| Vehicle | Local Tolerability (Scaling) | Moderate | 1 participants |
Secondary
Local Tolerability (Stinging/Burning)
Highest severity of local tolerability scores worse than Baseline
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD1579 2.5% | Local Tolerability (Stinging/Burning) | Mild | 19 participants |
| CD1579 2.5% | Local Tolerability (Stinging/Burning) | Moderate | 6 participants |
| CD1579 5% | Local Tolerability (Stinging/Burning) | Mild | 29 participants |
| CD1579 5% | Local Tolerability (Stinging/Burning) | Moderate | 7 participants |
| Vehicle | Local Tolerability (Stinging/Burning) | Mild | 4 participants |
| Vehicle | Local Tolerability (Stinging/Burning) | Moderate | 1 participants |
Secondary
Percent of Subjects With Adverse Events
Adverse events which were observed in 5% or more patients with either group are listed.
Time frame: up to 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD1579 2.5% | Percent of Subjects With Adverse Events | % of subjects with AEs | 43.0 percentage of participants |
| CD1579 2.5% | Percent of Subjects With Adverse Events | Nasopharyngitis | 12.7 percentage of participants |
| CD1579 2.5% | Percent of Subjects With Adverse Events | Headache | 10.1 percentage of participants |
| CD1579 2.5% | Percent of Subjects With Adverse Events | Dysmenorrhea | 6.3 percentage of participants |
| CD1579 5% | Percent of Subjects With Adverse Events | Dysmenorrhea | 3.8 percentage of participants |
| CD1579 5% | Percent of Subjects With Adverse Events | % of subjects with AEs | 39.7 percentage of participants |
| CD1579 5% | Percent of Subjects With Adverse Events | Headache | 1.3 percentage of participants |
| CD1579 5% | Percent of Subjects With Adverse Events | Nasopharyngitis | 14.1 percentage of participants |
| Vehicle | Percent of Subjects With Adverse Events | Dysmenorrhea | 3.8 percentage of participants |
| Vehicle | Percent of Subjects With Adverse Events | Nasopharyngitis | 13.9 percentage of participants |
| Vehicle | Percent of Subjects With Adverse Events | Headache | 8.9 percentage of participants |
| Vehicle | Percent of Subjects With Adverse Events | % of subjects with AEs | 32.9 percentage of participants |