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

P Acnes Colonization Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907101
• Other study ID #: US10127
• Status: Completed
• Phase: Phase 4
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: February 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Hypersensitivity
• P Acnes Colonization

Intervention

Drug:
• Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Apply once daily

Locations

Country	Name	City	State
United States	Skin Study Center	Broomall	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Quantitative Bacteriology Measurements at 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.	Week 4
Secondary	Worst Post Baseline Tolerability Assessment - Erythema	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.	Week 4
Secondary	Worst Post Baseline Tolerability Assessment - Dryness	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.	Week 4
Secondary	Worst Post Baseline Tolerability Assessment - Scaling	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.	Week 4
Secondary	Worst Post Baseline Tolerability Assessment - Stinging/Burning	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.	Week 4