Completed

NCT Number: NCT00907101

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

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.

Completed

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Key information

Conditions

P Acnes Colonization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skin Study Center

Broomall, Pennsylvania, 19008, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Apply once daily

Other names: Epiduo® Gel

Primary outcomes

Change From Baseline in Quantitative Bacteriology Measurements at Week 4

Time frame: 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 outcomes

Worst Post Baseline Tolerability Assessment - Erythema

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Evaluation of the Effectiveness of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) in Reducing Antibiotic Sensitive and Resistant Strains of P Acnes

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: May 22, 2009
Registry last updated: Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.