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

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

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.

Study Overview

• Status: Completed
• Conditions: P Acnes Colonization
• Intervention / Treatment: Drug: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Skin Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Epiduo® Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Galderma R&D

Publications and helpful links

General Publications

• Leyden JJ, Preston N, Osborn C, Gottschalk RW. In-vivo Effectiveness of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel on Antibiotic-sensitive and Resistant Propionibacterium acnes. J Clin Aesthet Dermatol. 2011 May;4(5):22-6.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: May 20, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (ESTIMATE): May 22, 2009

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Hypersensitivity; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Benzoyl Peroxide; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination
• Other Study ID Numbers: US10127