Phase 4 N=40 Randomized Single-blind Treatment

Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT01188538 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcome: Primary: Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes — -1.94; -1.56 Log10 cfu/cm²

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Epiduo gel (Drug); BPO (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes	-1.94; -1.56	—
SECONDARY Percent Change (%) in Inflammatory Lesion Counts	-62.8; -68.1	—

Summary

The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.

Eligibility Criteria

Inclusion Criteria

Subjects with facial acne,
Subjects with high levels of P. acnes counts on the forehead

Exclusion Criteria

Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
Subjects with acne conglobata, acne fulminans, secondary acne
Subjects with known or suspected allergy to one of the test product

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01188538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.