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

February 16, 2021 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Iwonicz Zdrój, Poland, 38-440
        • Dermatologiczna Klinika Uzdrowiskowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: Epiduo gel
Once daily application on the face in the evening for 12 weeks
Other Names:
  • Epiduo
ACTIVE_COMPARATOR: BPO gel
  • 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
Drug: BPO
Once daily application on the face in the evening for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Andrzej LANGNER, Professor, Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (ESTIMATE)

August 25, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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