Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.

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

Details

• Lead Sponsor: Galderma Laboratories, L.P.
• Treatments: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Anti-Bacterial Agents; Benzoyl Peroxide

Criteria

Inclusion Criteria:

• Healthy adult male or female subjects 18 years of age and older, with no past or present history of any significant internal disease

• Subjects who:

• show a high degree of fluorescence of the facial skin under a Wood's lamp, indicating the presence of P acnes

• have Baseline P acnes count of > 10,000 per cm2 CFU of the facial skin (forehead)

• have high level resistance to erythromycin, variable resistance to clindamycin, resistance to tetracycline and variable resistance to doxycycline and minocycline

Exclusion Criteria:

• Subjects who exhibit any skin disorders of an acute or chronic nature (e.g., psoriasis, eczema, etc)

• Subjects who have taken topical or systemic antibiotics within 4 weeks prior to baseline assessments

• Subjects who have used other medications which may influence skin surface P acnes levels

• Subjects who are unwilling to refrain from using toners, astringents or other drying agents on the face during the study