Phase 4
N=30
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
P Acnes Colonization
Bottom Line
View on ClinicalTrials.gov: NCT00907101 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Change From Baseline in Quantitative Bacteriology Measurements at Week 4 — -1.6 log10 CFU/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Quantitative Bacteriology Measurements at Week 4 |
-1.6 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Erythema |
30; 0 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Dryness |
26; 4 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Scaling |
29; 1 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Stinging/Burning |
29; 1 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00907101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.