Acne Vulgaris
Conditions
Keywords
Acne vulgaris, Adapalene, Benzoyl Peroxide
Brief summary
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.
Interventions
Topical Gel, One application daily in the evening for 12 weeks
DRUGAdapalene
Topical Gel,One application daily in the evening for 12 weeks
DRUGBenzoyl Peroxide
Topical Gel, one application daily in the evening for 12 weeks
Topical Gel Vehicle,one application daily in the evening for 12 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of acne vulgaris with facial involvement. * A minimum of 20 but not more than 50 Inflammatory lesions * A minimum of 30 but not more than 100 Noninflammatory lesions * A score of 3 (Moderate) on the Investigator's Global Assessment Scale.
Exclusion criteria
* More than one acne nodule or any acne cyst. * Acne conglobata, acne fulminans, secondary acne, or severe acne. * Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial. * Underlying diseases that require the use of interfering topical or systemic therapy. * Use of prohibited medications prior to the study unless appropriate washout period is documented * Use of hormonal contraceptives solely for control of acne
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate on the Investigator's Global Assessment | at week 12 | Percentage of subjects rated Clear and Almost Clear on 5-point scale (0=clear; 4=severe) |
| Changes in Inflammatory Lesion Counts | from Baseline to week 12 | Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts |
| Changes in Noninflammatory Lesion Counts | from Baseline to week 12 | Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Inflammatory Lesion Counts | at week 12 | Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 |
| Percent Change in Noniflammatory Lesion Counts | at week 12 | Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 |
| Percent Change in Total Lesion Counts | at week 12 | Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 |
Countries
Canada, Germany, Hungary, Poland, United States
Participant flow
Recruitment details
Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007. Types of locations: Dermatology Clinics, Dermatology Research Centers.
Pre-assignment details
The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).
Participants by arm
| Arm | Count |
|---|---|
| Adapalene/Benzoyl Peroxide Gel Adapalene/Benzoyl Peroxide Topical Gel | 419 |
| Adapalene Gel Adapalene Topical Gel | 418 |
| Benzoyl Peroxide Gel Benzoyl Peroxide Topical Gel | 415 |
| Gel Vehicle Topical Gel Vehicle | 418 |
| Total | 1,670 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 1 | 6 | 4 |
| Overall Study | Lack of Efficacy | 0 | 3 | 0 | 5 |
| Overall Study | Lost to Follow-up | 18 | 19 | 22 | 20 |
| Overall Study | Pregnancy | 0 | 1 | 1 | 2 |
| Overall Study | Protocol Violation | 2 | 2 | 0 | 1 |
| Overall Study | Subject transportation issues | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 22 | 23 | 23 | 24 |
Baseline characteristics
| Characteristic | Adapalene/Benzoyl Peroxide Gel | Adapalene Gel | Benzoyl Peroxide Gel | Gel Vehicle | Total |
|---|---|---|---|---|---|
| Age, Continuous | 19.5 years STANDARD_DEVIATION 6.7 | 18.5 years STANDARD_DEVIATION 6.3 | 18.9 years STANDARD_DEVIATION 6.96 | 19.2 years STANDARD_DEVIATION 7.23 | 19 years STANDARD_DEVIATION 6.81 |
| Age, Customized 12-17 years | 233 participants | 241 participants | 244 participants | 243 participants | 961 participants |
| Age, Customized >=65 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized Between 18 and 64 years | 186 participants | 177 participants | 171 participants | 175 participants | 709 participants |
| Region of Enrollment Canada | 102 participants | 100 participants | 100 participants | 101 participants | 403 participants |
| Region of Enrollment Europe | 132 participants | 133 participants | 136 participants | 132 participants | 533 participants |
| Region of Enrollment United States | 185 participants | 185 participants | 179 participants | 185 participants | 734 participants |
| Sex: Female, Male Female | 236 Participants | 229 Participants | 230 Participants | 244 Participants | 939 Participants |
| Sex: Female, Male Male | 183 Participants | 189 Participants | 185 Participants | 174 Participants | 731 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 90 / 419 | 60 / 418 | 35 / 415 | 22 / 418 |
| serious Total, serious adverse events | 3 / 419 | 1 / 418 | 1 / 415 | 2 / 418 |
Outcome results
Primary
Changes in Inflammatory Lesion Counts
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Time frame: from Baseline to week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Changes in Inflammatory Lesion Counts | -18 Lesion count |
| Adapalene Gel | Changes in Inflammatory Lesion Counts | -15 Lesion count |
| Benzoyl Peroxide Gel | Changes in Inflammatory Lesion Counts | -16 Lesion count |
| Gel Vehicle | Changes in Inflammatory Lesion Counts | -12 Lesion count |
Primary
Changes in Noninflammatory Lesion Counts
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Time frame: from Baseline to week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Changes in Noninflammatory Lesion Counts | -28 Lesion count |
| Adapalene Gel | Changes in Noninflammatory Lesion Counts | -24 Lesion count |
| Benzoyl Peroxide Gel | Changes in Noninflammatory Lesion Counts | -23 Lesion count |
| Gel Vehicle | Changes in Noninflammatory Lesion Counts | -18 Lesion count |
Primary
Success Rate on the Investigator's Global Assessment
Percentage of subjects rated Clear and Almost Clear on 5-point scale (0=clear; 4=severe)
Time frame: at week 12
Population: Intention to treat (ITT), last observation carried forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Success Rate on the Investigator's Global Assessment | 37.9 Percentage of participants |
| Adapalene Gel | Success Rate on the Investigator's Global Assessment | 21.8 Percentage of participants |
| Benzoyl Peroxide Gel | Success Rate on the Investigator's Global Assessment | 26.7 Percentage of participants |
| Gel Vehicle | Success Rate on the Investigator's Global Assessment | 17.9 Percentage of participants |
Secondary
Percent Change in Inflammatory Lesion Counts
Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time frame: at week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Percent Change in Inflammatory Lesion Counts | -61.7 Percent change | Standard Deviation 33.9 |
| Adapalene Gel | Percent Change in Inflammatory Lesion Counts | -50.1 Percent change | Standard Deviation 39.4 |
| Benzoyl Peroxide Gel | Percent Change in Inflammatory Lesion Counts | -52.2 Percent change | Standard Deviation 39.4 |
| Gel Vehicle | Percent Change in Inflammatory Lesion Counts | -40.8 Percent change | Standard Deviation 41.1 |
Secondary
Percent Change in Noniflammatory Lesion Counts
Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time frame: at week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Percent Change in Noniflammatory Lesion Counts | -55.6 Percent change | Standard Deviation 35.3 |
| Adapalene Gel | Percent Change in Noniflammatory Lesion Counts | -46.0 Percent change | Standard Deviation 33.7 |
| Benzoyl Peroxide Gel | Percent Change in Noniflammatory Lesion Counts | -44.1 Percent change | Standard Deviation 37.3 |
| Gel Vehicle | Percent Change in Noniflammatory Lesion Counts | -32.3 Percent change | Standard Deviation 39.5 |
Secondary
Percent Change in Total Lesion Counts
Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time frame: at week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Percent Change in Total Lesion Counts | -57.7 Percent change | Standard Deviation 31.9 |
| Adapalene Gel | Percent Change in Total Lesion Counts | -47.5 Percent change | Standard Deviation 31.3 |
| Benzoyl Peroxide Gel | Percent Change in Total Lesion Counts | -47.2 Percent change | Standard Deviation 32.7 |
| Gel Vehicle | Percent Change in Total Lesion Counts | -35.2 Percent change | Standard Deviation 36 |