Acne Vulgaris
Conditions
Keywords
Acne vulgaris, Adapalene, Benzoyl Peroxide
Brief summary
This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were 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 participant should remain the same during the study. The primary objective was 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
Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
0.1% of adapalene gel topically daily in the evening for 12 Weeks.
DRUGBenzoyl Peroxide Gel 2.5%
2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
DRUGGel Vehicle
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | At Week 12 | Success rate was defined as percentage of participants who achieved Clear or Almost Clear score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF. |
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. |
| Change in Noninflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | Baseline, Week 12 | The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF. |
| Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | Baseline, Week 12 | The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF. |
| Percent Change From Baseline in Total Lesion Counts at Week 12 | Baseline, Week 12 | The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts. |
Countries
United States
Participant flow
Pre-assignment details
A total of 1668 participants with acne vulgaris were randomized, administered and enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Adapalene/Benzoyl Peroxide Gel Participants were treated with adapalene 0.1 % (W/W)/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. | 415 |
| Adapalene Gel, 0.1% Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. | 420 |
| Benzoyl Peroxide Gel 2.5% Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. | 415 |
| Gel Vehicle Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. | 418 |
| Total | 1,668 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 4 | 5 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 31 | 32 | 19 | 34 |
| Overall Study | Other | 1 | 0 | 0 | 1 |
| Overall Study | Pregnancy | 3 | 1 | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 |
| Overall Study | Subject request | 21 | 17 | 18 | 30 |
Baseline characteristics
| Characteristic | Adapalene/Benzoyl Peroxide Gel | Adapalene Gel, 0.1% | Benzoyl Peroxide Gel 2.5% | Gel Vehicle | Total |
|---|---|---|---|---|---|
| Age, Continuous | 18.7 years STANDARD_DEVIATION 7.14 | 17.9 years STANDARD_DEVIATION 5.4 | 18.4 years STANDARD_DEVIATION 6.55 | 18.0 years STANDARD_DEVIATION 6.09 | 18.2 years STANDARD_DEVIATION 6.33 |
| Race/Ethnicity, Customized Asian | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 17 Participants |
| Race/Ethnicity, Customized Black | 66 Participants | 64 Participants | 81 Participants | 66 Participants | 277 Participants |
| Race/Ethnicity, Customized Caucasian | 273 Participants | 281 Participants | 258 Participants | 270 Participants | 1082 Participants |
| Race/Ethnicity, Customized Hispanic | 67 Participants | 66 Participants | 65 Participants | 72 Participants | 270 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 5 Participants | 7 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Female | 210 Participants | 217 Participants | 207 Participants | 222 Participants | 856 Participants |
| Sex: Female, Male Male | 205 Participants | 203 Participants | 208 Participants | 196 Participants | 812 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 | 0 / 415 | 0 / 420 | 0 / 415 | 0 / 418 |
| other Total, other adverse events | 44 / 415 | 51 / 420 | 29 / 415 | 34 / 418 |
| serious Total, serious adverse events | 2 / 415 | 3 / 420 | 0 / 415 | 1 / 418 |
Outcome results
Primary
Change in Inflammatory Lesion Count From Baseline to Week 12
Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Time frame: Baseline to Week 12
Population: ITT Population included all treated participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline | 27.0 lesions |
| Adapalene/Benzoyl Peroxide Gel | Change in Inflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -16.0 lesions |
| Adapalene Gel, 0.1% | Change in Inflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -14.0 lesions |
| Adapalene Gel, 0.1% | Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline | 27.0 lesions |
| Benzoyl Peroxide Gel 2.5% | Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline | 27.0 lesions |
| Benzoyl Peroxide Gel 2.5% | Change in Inflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -16.0 lesions |
| Gel Vehicle | Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline | 27.0 lesions |
| Gel Vehicle | Change in Inflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -10.0 lesions |
Primary
Change in Noninflammatory Lesion Count From Baseline to Week 12
Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Time frame: Baseline to Week 12
Population: ITT Population included all treated participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Baseline | 44.0 lesions |
| Adapalene/Benzoyl Peroxide Gel | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -24.0 lesions |
| Adapalene Gel, 0.1% | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -22.0 lesions |
| Adapalene Gel, 0.1% | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Baseline | 47.0 lesions |
| Benzoyl Peroxide Gel 2.5% | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Baseline | 46.0 lesions |
| Benzoyl Peroxide Gel 2.5% | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -20.0 lesions |
| Gel Vehicle | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Baseline | 46.0 lesions |
| Gel Vehicle | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Change at Week 12 | -14.0 lesions |
Primary
Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)
Success rate was defined as percentage of participants who achieved Clear or Almost Clear score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
Time frame: At Week 12
Population: ITT (Intent-To-Treat) Population included all treated participants. Here, Overall Number of Participants Analyzed = Participants with available data for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | 30.1 percentage of participants |
| Adapalene Gel, 0.1% | Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | 19.8 percentage of participants |
| Benzoyl Peroxide Gel 2.5% | Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | 22.2 percentage of participants |
| Gel Vehicle | Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | 11.3 percentage of participants |
Secondary
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Time frame: Baseline, Week 12
Population: ITT Population included all treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -55.33 percent change | Standard Deviation 34.678 |
| Adapalene Gel, 0.1% | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -41.68 percent change | Standard Deviation 41.855 |
| Benzoyl Peroxide Gel 2.5% | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -47.61 percent change | Standard Deviation 38.415 |
| Gel Vehicle | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -30.23 percent change | Standard Deviation 41.661 |
Secondary
Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12
The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Time frame: Baseline, Week 12
Population: ITT Population included all treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | -48.15 percent change | Standard Deviation 35.428 |
| Adapalene Gel, 0.1% | Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | -40.75 percent change | Standard Deviation 40.822 |
| Benzoyl Peroxide Gel 2.5% | Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | -37.23 percent change | Standard Deviation 39.758 |
| Gel Vehicle | Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | -23.22 percent change | Standard Deviation 48.613 |
Secondary
Percent Change From Baseline in Total Lesion Counts at Week 12
The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts.
Time frame: Baseline, Week 12
Population: ITT Population included all treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Percent Change From Baseline in Total Lesion Counts at Week 12 | -49.97 percent change in lesions | Standard Deviation 31.966 |
| Adapalene Gel, 0.1% | Percent Change From Baseline in Total Lesion Counts at Week 12 | -41.29 percent change in lesions | Standard Deviation 36.133 |
| Benzoyl Peroxide Gel 2.5% | Percent Change From Baseline in Total Lesion Counts at Week 12 | -41.23 percent change in lesions | Standard Deviation 33.794 |
| Gel Vehicle | Percent Change From Baseline in Total Lesion Counts at Week 12 | -26.06 percent change in lesions | Standard Deviation 38.714 |