Trial | NCT00441415  Report issue

Title

Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    adapalene ...

  • Study Participants

    272
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.
Study Started
Feb 28
2007
Primary Completion
Oct 31
2007
Study Completion
Oct 31
2007
Last Update
Feb 17
2021

Drug Adapalene BPO

Criteria 

Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.

Main inclusion criteria:

Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.

Main exclusion criteria:

Subjects with acne cystic lesions,
Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
No Results Posted