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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Anti-Infective Agents; Benzoyl Peroxide; Clindamycin

Criteria

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