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

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Epiduo gel; Drug: BPO

• Registration Number: NCT01188538
• Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Results First Submitted: 2011-06-09
• Results First Submitted QC: 2011-06-09
• Status Verified: 2011-07
• Results First Posted: 2011-07-07
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epiduo gel	Epiduo gel	* Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:Topical to the face, once daily application in the evening. * Duration of Treatment:12 weeks
BPO gel	BPO	* Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:Topical to the face, once daily application in the evening. * Duration of Treatment:12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes	Week 12	Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes.; Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study.

Secondary Outcome Measures

Name	Time	Method
Percent Change (%) in Inflammatory Lesion Counts	Week 12	Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.

Trial Locations

Locations (1)

Dermatologiczna Klinika Uzdrowiskowa; 🇵🇱 Iwonicz Zdrój, Poland