Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, Adapalene
Brief summary
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
Detailed description
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.
Interventions
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Vehicle will be applied topically to the face, once a day, 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
* Subjects with Moderate or Severe Acne Vulgaris, * 20-50 papules and pustules in total on the face excluding the nose * 30-100 non-inflammatory lesions on the face excluding the nose. * Negative urine pregnancy test for all females.
Exclusion criteria
* Subjects with more than one acne nodule. * Subjects with any acne cyst on the face. * Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. * Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. * Subjects who are pregnant, nursing, or planning a pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 | From Baseline to Week 12 | Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe. |
| Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 | Baseline to 12 weeks | — |
| Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | — |
| Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 | Baseline to Week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Total Lesion Count From Baseline to Week 12 | From Baseline to 12 weeks | Percent change in lesion count from baseline to week 12 |
Countries
Canada, United States
Participant flow
Recruitment details
Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008
Pre-assignment details
Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies.
Participants by arm
| Arm | Count |
|---|---|
| Adapalene Lotion 0.1% once a day for 12 weeks | 535 |
| Adapalene Lotion Vehicle 0% once a day for 12 weeks | 531 |
| Total | 1,066 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lack of Efficacy | 4 | 8 |
| Overall Study | Lost to Follow-up | 23 | 23 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 28 | 34 |
Baseline characteristics
| Characteristic | Adapalene Lotion 0.1% | Adapalene Lotion Vehicle 0% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 338 Participants | 336 Participants | 674 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 197 Participants | 195 Participants | 392 Participants |
| Age, Continuous | 19.1 years STANDARD_DEVIATION 6.8 | 19.2 years STANDARD_DEVIATION 7.3 | 19.15 years STANDARD_DEVIATION 7.05 |
| Region of Enrollment Canada | 48 participants | 47 participants | 95 participants |
| Region of Enrollment United States | 487 participants | 484 participants | 971 participants |
| Sex: Female, Male Female | 300 Participants | 272 Participants | 572 Participants |
| Sex: Female, Male Male | 235 Participants | 259 Participants | 494 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 535 | 11 / 531 |
| serious Total, serious adverse events | 0 / 535 | 0 / 531 |
Outcome results
Primary
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time frame: Baseline to Week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Adapalene Lotion 0.1% | Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 | 13.0 Absolute Change in Infl Lesion count | Standard Error 0.5 |
| Adapalene Lotion Vehicle 0% | Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 | 10.4 Absolute Change in Infl Lesion count | Standard Error 0.5 |
Primary
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time frame: Baseline to Week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Adapalene Lotion 0.1% | Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 | 19.5 Absolute Change in Non-Infl Lesion | Standard Error 0.8 |
| Adapalene Lotion Vehicle 0% | Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 | 12.9 Absolute Change in Non-Infl Lesion | Standard Error 0.8 |
Primary
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Adapalene Lotion 0.1% | Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 | 32.5 Absolute Change in Total Lesion Count | Standard Error 1 |
| Adapalene Lotion Vehicle 0% | Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 | 23.3 Absolute Change in Total Lesion Count | Standard Error 1 |
Primary
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe.
Time frame: From Baseline to Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene Lotion 0.1% | Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 | 24.1 Percentage of Participants |
| Adapalene Lotion Vehicle 0% | Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 | 16.4 Percentage of Participants |
Secondary
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Percent change in lesion count from baseline to week 12
Time frame: From Baseline to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene Lotion 0.1% | Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Total lesion count | -44.6 % Change in Lesion Count | Standard Deviation 33.2 |
| Adapalene Lotion 0.1% | Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Inflammatory | -46.0 % Change in Lesion Count | Standard Deviation 36.8 |
| Adapalene Lotion 0.1% | Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Non-Inflammatory | -43.1 % Change in Lesion Count | Standard Deviation 40.9 |
| Adapalene Lotion Vehicle 0% | Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Total lesion count | -32.8 % Change in Lesion Count | Standard Deviation 34.1 |
| Adapalene Lotion Vehicle 0% | Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Inflammatory | -36.9 % Change in Lesion Count | Standard Deviation 40.7 |
| Adapalene Lotion Vehicle 0% | Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Non-Inflammatory | -30.2 % Change in Lesion Count | Standard Deviation 40.5 |