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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00907101
First received: May 20, 2009
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
P Acnes Colonization
Drug: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Change From Baseline in Quantitative Bacteriology Measurements at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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:
  • Worst Post Baseline Tolerability Assessment - Erythema [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Treatment

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

Other Names:

Epiduo® Gel Apply once daily

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907101

Locations
United States, Pennsylvania
Skin Study Center
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00907101     History of Changes
Other Study ID Numbers: US10127 
Study First Received: May 20, 2009
Results First Received: August 12, 2014
Last Updated: February 16, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Anti-Infective Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 23, 2016