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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Epiduo gel

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

BPO

Intervention Type DRUG

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

Interventions

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Epiduo gel

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

Intervention Type DRUG

BPO

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

Intervention Type DRUG

Other Intervention Names

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Epiduo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No