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

Phase 4

Completed

Conditions: P Acnes Colonization

Interventions: Drug: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)

Registration Number: NCT00907101

Lead Sponsor: Galderma R&D

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Treatment	Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)	Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) Other Names: Epiduo® Gel Apply once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Quantitative Bacteriology Measurements at Week 4	Week 4	Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².

Secondary Outcome Measures

Name	Time	Method
Worst Post Baseline Tolerability Assessment - Erythema	Week 4	Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Worst Post Baseline Tolerability Assessment - Dryness	Week 4	Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Worst Post Baseline Tolerability Assessment - Scaling	Week 4	Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Worst Post Baseline Tolerability Assessment - Stinging/Burning	Week 4	Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.