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OpenTrials
Completed

NCT Number: NCT01188538

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dermatologiczna Klinika Uzdrowiskowa

Iwonicz-Zdrój, 38-440, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epiduo Gel

Drug

Once daily application on the face in the evening for 12 weeks

Other names: Epiduo

BPO

Drug

Once daily application on the face in the evening for 12 weeks

Primary outcomes

  1. Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes

    Time frame: 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 outcomes

  1. Percent Change (%) in Inflammatory Lesion Counts

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2010
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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