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

Study Overview
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Brief Summary
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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
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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

Official Title
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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
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Acne

Intervention / Treatment
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* Drug: Benzoyl peroxide with clindamycin
* Drug: Benzoyl peroxide with clindamycin and doxycycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BPO with clindamycin foam<br>Benzoyl peroxide (BPO) wash with clindamycin foam | Drug: Benzoyl peroxide with clindamycin<br>* Benzoyl peroxide wash - Clindamycin foam<br>* Other names: Acne;|
| Active Comparator: BPO + clindamycin foam + doxycycline<br>Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules | Drug: Benzoyl peroxide with clindamycin and doxycycline<br>* Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules<br>* Other names: Acne;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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) | 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 Almost Clear 1.5- Almost Clear/Mild Mild 2.5- Mild/Moderate Moderate 3.5- Moderate/Severe | Baseline, Weeks 4, 8,12, and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 Almost Clear 1.5- Almost Clear/Mild Mild 2.5- Mild/Moderate Moderate 3.5- Moderate/Severe | Baseline, Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne