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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: October 1, 2012
Last verified: September 2012
History of Changes
  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:

MedlinePlus related topics: Acne Antibiotics
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Tolerability assessments [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

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
Active Comparator: 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
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
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

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00907101     History of Changes
Other Study ID Numbers: US10127
Study First Received: May 20, 2009
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Anti-Bacterial Agents
Adapalene
Benzoyl Peroxide
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013