Acne
Conditions
Keywords
Acne
Brief summary
To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne
Detailed description
To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne
Interventions
DRUGBenzoyl peroxide with clindamycin
Benzoyl peroxide wash - Clindamycin foam
DRUGBenzoyl peroxide with clindamycin and doxycycline
Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.
Exclusion criteria
* Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator Global Assessment (IGA) | Baseline, Weeks 4, 8,12, and 16 | Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear 1. Almost Clear 1.5- Almost Clear/Mild 2. Mild 2.5- Mild/Moderate 3. Moderate 3.5- Moderate/Severe |
| Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 | Baseline, Week 16 | Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back) |
| Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. | Baseline, Week 16 | Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16. |
| Percent Change in Total Acne Lesion Counts From Baseline to Week 16 | Baseline, Week 16 | Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 | Baseline, Week 12 | Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12 |
| Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 | Baseline, Week 12 | Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12 |
| Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 | Week 12 | Percent change in total lesions (chest and back) from baseline to Week 12 |
| Percentage of Particpants With IGA Score at Week 16 | Baseline, Week 16 | Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment IGA: 0 - Clear 0.5 - Clear/almost clear 1. Almost Clear 1.5- Almost Clear/Mild 2. Mild 2.5- Mild/Moderate 3. Moderate 3.5- Moderate/Severe |
Countries
United States
Participant flow
Recruitment details
Recruitment period: First Subject Enrolled May 2008, Last Subject completed August 28, 2008. Types of location: Dermatology Research Center
Participants by arm
| Arm | Count |
|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. | 16 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day. | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | not stated | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Total | Benzoyl Peroxide Wash -Clindamycin Foam |
|---|---|---|---|
| Age, Continuous | 21.9 years STANDARD_DEVIATION 6.9 | 22.9 years STANDARD_DEVIATION 7.7 | 23.9 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Asian | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 22 Participants | 10 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 13 | 4 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Change in Investigator Global Assessment (IGA)
Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear 1. Almost Clear 1.5- Almost Clear/Mild 2. Mild 2.5- Mild/Moderate 3. Moderate 3.5- Moderate/Severe
Time frame: Baseline, Weeks 4, 8,12, and 16
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 4 | -0.42 Units on a scale | Standard Deviation 0.57 |
| Benzoyl Peroxide Wash -Clindamycin Foam | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 8 | -0.55 Units on a scale | Standard Deviation 0.88 |
| Benzoyl Peroxide Wash -Clindamycin Foam | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 12 | -1 Units on a scale | Standard Deviation 1.07 |
| Benzoyl Peroxide Wash -Clindamycin Foam | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 16 | -0.9 Units on a scale | Standard Deviation 0.94 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 16 | -1.25 Units on a scale | Standard Deviation 0.97 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 4 | -0.61 Units on a scale | Standard Deviation 0.59 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 12 | -1.09 Units on a scale | Standard Deviation 0.8 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Change in Investigator Global Assessment (IGA) | Change from Baseline to Week 8 | -0.85 Units on a scale | Standard Deviation 0.72 |
Primary
Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
Time frame: Baseline, Week 16
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 | -52.70 Percent change | Standard Deviation 26.83 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 | -48.84 Percent change | Standard Deviation 40.37 |
Primary
Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
Time frame: Baseline, Week 16
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. | -25.27 Percent Change | Standard Deviation 45.64 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. | -44.69 Percent Change | Standard Deviation 43.72 |
Primary
Percent Change in Total Acne Lesion Counts From Baseline to Week 16
Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
Time frame: Baseline, Week 16
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Percent Change in Total Acne Lesion Counts From Baseline to Week 16 | -38.49 Percent Change | Standard Deviation 33.06 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percent Change in Total Acne Lesion Counts From Baseline to Week 16 | -46.11 Percent Change | Standard Deviation 39.74 |
Secondary
Percentage of Particpants With IGA Score at Week 16
Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment IGA: 0 - Clear 0.5 - Clear/almost clear 1. Almost Clear 1.5- Almost Clear/Mild 2. Mild 2.5- Mild/Moderate 3. Moderate 3.5- Moderate/Severe
Time frame: Baseline, Week 16
Population: Subjects who completed week 16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Percentage of Particpants With IGA Score at Week 16 | % Moderate | 30 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam | Percentage of Particpants With IGA Score at Week 16 | % Clear skin | 0 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam | Percentage of Particpants With IGA Score at Week 16 | % Clear or Almost Clear | 0 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam | Percentage of Particpants With IGA Score at Week 16 | % Almost Clear | 30 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam | Percentage of Particpants With IGA Score at Week 16 | % Almost clear/ mild | 10 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam | Percentage of Particpants With IGA Score at Week 16 | % Mild | 10 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam | Percentage of Particpants With IGA Score at Week 16 | % Mild/ Moderate | 20 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percentage of Particpants With IGA Score at Week 16 | % Moderate | 16.7 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percentage of Particpants With IGA Score at Week 16 | % Almost clear/ mild | 8.3 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percentage of Particpants With IGA Score at Week 16 | % Clear skin | 8.3 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percentage of Particpants With IGA Score at Week 16 | % Mild/ Moderate | 8.3 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percentage of Particpants With IGA Score at Week 16 | % Clear or Almost Clear | 8.3 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percentage of Particpants With IGA Score at Week 16 | % Mild | 25 Percent of participants |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percentage of Particpants With IGA Score at Week 16 | % Almost Clear | 25 Percent of participants |
Secondary
Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12
Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12
Time frame: Baseline, Week 12
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 | -49.04 Percent Change | Standard Deviation 31.63 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 | -45.44 Percent Change | Standard Deviation 46.09 |
Secondary
Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12
Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12
Time frame: Baseline, Week 12
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 | -38.43 Percent change | Standard Deviation 39.75 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 | -38.52 Percent change | Standard Deviation 39.03 |
Secondary
Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12
Percent change in total lesions (chest and back) from baseline to Week 12
Time frame: Week 12
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 | -44.16 Percent change | Standard Deviation 29.41 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 | -41.74 Percent change | Standard Deviation 38.56 |