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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-01-31

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.

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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.

Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Duac gel

Clindamycin and benzoyl peroxide gel

Group Type ACTIVE_COMPARATOR

Duac

Intervention Type DRUG

Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks

Ziana gel

Clindamycin and tretinoin gel

Group Type ACTIVE_COMPARATOR

Ziana gel

Intervention Type DRUG

Clindamycin and tretinoin gel once a day for 12 weeks.

Interventions

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Duac

Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks

Intervention Type DRUG

Ziana gel

Clindamycin and tretinoin gel once a day for 12 weeks.

Intervention Type DRUG

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No