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

Acne Vulgaris Clinical Trial

Official title:

Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188538
• Other study ID #: RD.03.SPR.29084
• Status: Completed
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: July 2011
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Epiduo gel
Once daily application on the face in the evening for 12 weeks
• BPO
Once daily application on the face in the evening for 12 weeks

Locations

Country	Name	City	State
Poland	Dermatologiczna Klinika Uzdrowiskowa	Iwonicz Zdrój

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes	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.	Week 12
Secondary	Percent Change (%) in Inflammatory Lesion Counts	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.	Week 12

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