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

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: P Acnes Colonization

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

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Change from baseline in quantitative bacteriology measurements at week 4

Secondary outcome: Tolerability assessments

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Skin Study Center, Broomall, Pennsylvania 19008, United States
Additional Information

Starting date: June 2009
Last updated: October 1, 2012

Page last updated: August 23, 2015

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