Acne
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.
Interventions
daily topical application for 12 weeks
daily topical application for 12 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of acne vulgaris with facial involvement * Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale * A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline
Exclusion criteria
* Acne nodule or acne cyst * Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment * Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments * Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | Baseline to Week 12 (Last Observation Carried Forward [LOCF]) | Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA) |
| Change From Baseline in Total Lesion Counts | Baseline to Week 12 (LOCF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change in Total Lesion Counts From Baseline | Baseline to Week 12 (LOCF) |
| Change in Inflammatory Lesion Counts From Baseline | Baseline to Week 12 (LOCF) |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adapalene/Benzoyl Peroxide Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks | 142 |
| Topical Gel Vehicle Topical Gel Vehicle applied topically once daily for 12 weeks | 143 |
| Total | 285 |
Baseline characteristics
| Characteristic | Adapalene/Benzoyl Peroxide | Topical Gel Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 142 Participants | 143 Participants | 285 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.3 years STANDARD_DEVIATION 0.76 | 10.4 years STANDARD_DEVIATION 0.68 | 10.4 years STANDARD_DEVIATION 0.72 |
| Region of Enrollment Canada | 12 participants | 14 participants | 26 participants |
| Region of Enrollment United States | 130 participants | 129 participants | 259 participants |
| Sex: Female, Male Female | 109 Participants | 108 Participants | 217 Participants |
| Sex: Female, Male Male | 33 Participants | 35 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 142 | 18 / 143 |
| serious Total, serious adverse events | 0 / 142 | 1 / 143 |
Outcome results
Primary
Change From Baseline in Total Lesion Counts
Time frame: Baseline to Week 12 (LOCF)
Population: ITT population, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide | Change From Baseline in Total Lesion Counts | -27.6 lesion count change | Standard Deviation 22.43 |
| Topical Gel Vehicle | Change From Baseline in Total Lesion Counts | -3.6 lesion count change | Standard Deviation 24.44 |
Comparison: null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)p-value: <0.001ANCOVA
Primary
Success Rate
Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)
Time frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Population: Intent to treat (ITT) population, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene/Benzoyl Peroxide | Success Rate | 47.2 percentage of participant |
| Topical Gel Vehicle | Success Rate | 15.4 percentage of participant |
Comparison: null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).~power calculation: 90%p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Change in Inflammatory Lesion Counts From Baseline
Time frame: Baseline to Week 12 (LOCF)
Population: ITT Population, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide | Change in Inflammatory Lesion Counts From Baseline | -7.4 lesion count change | Standard Deviation 12.46 |
| Topical Gel Vehicle | Change in Inflammatory Lesion Counts From Baseline | -0.7 lesion count change | Standard Deviation 12.46 |
p-value: <0.001ANCOVA
Secondary
Percent Change in Total Lesion Counts From Baseline
Time frame: Baseline to Week 12 (LOCF)
Population: ITT Population, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide | Percent Change in Total Lesion Counts From Baseline | -55.5 percentage of change in lesion count | Standard Deviation 38.99 |
| Topical Gel Vehicle | Percent Change in Total Lesion Counts From Baseline | -9.3 percentage of change in lesion count | Standard Deviation 48 |
p-value: <0.001Cochran-Mantel-Haenszel