Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne

Study Overview
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Brief Summary
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The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

Detailed Description
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To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.

Official Title
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Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris

Conditions
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Acne

Intervention / Treatment
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* Drug: Duac
* Drug: Ziana gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study. Mild to moderate facial acne vulgaris Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian. Exclusion Criteria: Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control Allergy or sensitivity to any component of the test medication Known hypersensitivity to to any component of the investigational formulations Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis Beards or sideburns Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris Evidence of recent alcohol or drug abuse Participation in an investigational drug study within 30 days of the baseline visit

Ages Eligible for Study
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Minimum Age: 12 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: Duac gel<br>Clindamycin and benzoyl peroxide gel | Drug: Duac<br>* Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks<br>|
| Active Comparator: Ziana gel<br>Clindamycin and tretinoin gel | Drug: Ziana gel<br>* Clindamycin and tretinoin gel once a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Change in Total Propionibacterium Acne (P.Acne) Counts | Median change in total colony forming units of propionibacterium acne (P.acne) will be counted. | Baseline, Weeks 2, 4, 8, 12, & 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Change in Clindamycin Resistant P. Acne. | Median change in total colony forming units of clindamycin resistant p. acne. | Baseline, Weeks 2, 4, 8, 12, 16 | 
| Median Change in Erythromycin-resistant P. Acne Counts | Total colony forming units of erythromycin-resistant p. acnes. | Baseline, Weeks 2, 4, 8, 12, and 16 | 
| Median Change in Total Acne Lesions | Median Change in Total Acne Lesions | Baseline, Weeks 2, 4, 8, 12, and 16 | 
| Median Change in Inflammatory Acne Lesion Counts | Median Change in Inflammatory Acne Lesion Counts | Baseline, Weeks 2, 4, 8, 12, and 16 | 
| Median Change in Noninflammaotry Acne Counts | Median Change in Noninflammaotry Acne Counts | Baseline, Weeks 2, 4, 8, 12, and 16 | 

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