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

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: BPO; Drug: Epiduo gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01188538

RD.03.SPR.29084

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Epiduo gel

Experimental group

Description:

* 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

Treatment:

Drug: Epiduo gel

BPO gel

Active Comparator group

Description:

* 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

Treatment:

Drug: BPO