A Phase 4 interventional study of Benzoyl peroxide with clindamycin and Benzoyl peroxide with clindamycin and doxycycline in Acne, sponsored by Stiefel, a GSK Company. Completed at 2 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by Stiefel, a GSK Company · Phase 4, Interventional, and Treatment
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
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
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 33 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Stiefel, a GSK Company is the lead sponsor of 55 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Benzoyl peroxide (BPO) wash with clindamycin foam
Drug: Benzoyl peroxide with clindamycin
Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules
Drug: Benzoyl peroxide with clindamycin and doxycycline
Benzoyl peroxide wash - Clindamycin foam
Also known as: Acne
Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules
Also known as: Acne
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
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
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
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
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
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
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
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
Recruitment period: First Subject Enrolled May 2008, Last Subject completed August 28, 2008. Types of location: Dermatology Research Center
| Milestone | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Started | 16 | 17 |
| Completed | 10 | 12 |
| Not completed | 6 | 5 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Not stated | 1 | 1 |
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
| Percent change | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 | -52.70 ± 26.83 | -48.84 ± 40.37 |
Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
| Percent Change | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. | -25.27 ± 45.64 | -44.69 ± 43.72 |
Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
| Percent Change | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Percent Change in Total Acne Lesion Counts From Baseline to Week 16 | -38.49 ± 33.06 | -46.11 ± 39.74 |
Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12
| Percent Change | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 | -49.04 ± 31.63 | -45.44 ± 46.09 |
Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12
| Percent change | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 | -38.43 ± 39.75 | -38.52 ± 39.03 |
Percent change in total lesions (chest and back) from baseline to Week 12
| Percent change | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 | -44.16 ± 29.41 | -41.74 ± 38.56 |
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
| Units on a scale | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Change from Baseline to Week 4 | -0.42 ± 0.57 | -0.61 ± 0.59 |
| Change from Baseline to Week 8 | -0.55 ± 0.88 | -0.85 ± 0.72 |
| Change from Baseline to Week 12 | -1 ± 1.07 | -1.09 ± 0.8 |
| Change from Baseline to Week 16 | -0.9 ± 0.94 | -1.25 ± 0.97 |
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
| Percent of participants | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| % Clear skin | 0 | 8.3 |
| % Clear or Almost Clear | 0 | 8.3 |
| % Almost Clear | 30 | 25 |
| % Almost clear/ mild | 10 | 8.3 |
| % Mild | 10 | 25 |
| % Mild/ Moderate | 20 | 8.3 |
| % Moderate | 30 | 16.7 |
Collected over 16 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | — | 0/13 (0%) | 4/13 (30.8%) |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | — | 0/14 (0%) | 4/14 (28.6%) |
| Event | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
|---|---|---|
| Cold/ Cold symptomsInfections and infestations | 2/13 | 1/14 |
| Stomach fluInfections and infestations | 1/13 | 0/14 |
| CoughInfections and infestations | 1/13 | 0/14 |
| HeadacheNervous system disorders | 0/13 | 1/14 |
| FeverInfections and infestations | 0/13 | 1/14 |
| Nausea/ vomitingInfections and infestations | 0/13 | 1/14 |
| DizzinessEar and labyrinth disorders | 0/13 | 1/14 |
| Age, Continuous(years) | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Total |
|---|---|---|---|
| Mean | 23.9 ± 8.5 | 21.9 ± 6.9 | 22.9 ± 7.7 |
| Sex: Female, Male(Participants) | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 9 | 8 | 17 |
| Race/Ethnicity, Customized(Participants) | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Total |
|---|---|---|---|
| White | 10 | 12 | 22 |
| Asian | 3 | 0 | 3 |
| Hispanic | 2 | 3 | 5 |
| Black or African American | 1 | 2 | 3 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Stiefel, a GSK Company