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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:5/26/2017
Start Date:August 2007
End Date:January 2009

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

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.

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.

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
We found this trial at
2
sites
Louisville, Kentucky 40202
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Louisville, KY
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5160 Socialville-Foster Road
Mason, Ohio 45040
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Mason, OH
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