Comparative 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
- Conditions
- Acne
- Interventions
- Registration Number
- NCT00837213
- Lead Sponsor
- Stiefel, a GSK Company
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BPO + clindamycin foam + doxycycline Benzoyl peroxide with clindamycin and doxycycline Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules BPO with clindamycin foam Benzoyl peroxide with clindamycin Benzoyl peroxide (BPO) wash with clindamycin foam
- Primary Outcome Measures
Name Time Method 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)
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Las Vegas Skin & Cancer Clinic
🇺🇸Las Vegas, Nevada, United States
Center for Dermatology, Cosmetic and Laser Surgery
🇺🇸Fremont, California, United States