Status:
COMPLETED
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
Lead Sponsor:
Galderma R&D
Conditions:
P Acnes Colonization
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00907101
Start Date
June 1 2009
End Date
July 1 2009
Last Update
August 1 2022
Active Locations (1)
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1
Skin Study Center
Broomall, Pennsylvania, United States, 19008