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

Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Adapalene BPO (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Elisabeth ARTHUR, MD, Affiliation: Helendale Dermatology - Rochester NY - 585-266-5420
Alicia BUCKO, MD, Affiliation: Academic Dermatology Associates - Albuquerque NM - 505-247-4220
Paul YAMAUCHI, MD, Affiliation: Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887
Steven E. KEMPERS, MD, Affiliation: Minnesota Clinical Study Center - Fridley MN - 763-571-4200
Harald GOLLNICK, MD, Principal Investigator, Affiliation: Otto-von-Guericke University - Magdeburg - Germany
Yvonne FRAMBACH, MD, Affiliation: Universitatsklinikum - Lubeck - Germany
Michael MEURER, MD, Affiliation: Dresden University - Dresden - Germany
Christos ZOUBOULIS, MD, Affiliation: Hautklinik und Immunologisches Zentrum des St├Ądtischen Klinikum - Dessau - Germany
Roland KAUFMANN, MD, Affiliation: Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany
Thomas SCHWARZ, MD, Affiliation: Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.

Secondary outcome:

Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit

Global severity assessment at each post Baseline visit

Eligibility

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

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: 1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris, 2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, 3. 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: 1. Subjects with acne cystic lesions, 2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).

Locations and Contacts

Paul YAMAUCHI, Santa Monica, California 90404, United States

Steven E. KEMPERS, Fridley, Minnesota 55432, United States

Dr Alicia BUCKO, Albuquerque, New Mexico 87106, United States

Elisabeth ARTHUR, Rochester, New York 14609, United States

Additional Information

Starting date: February 2007
Last updated: August 5, 2008

Page last updated: August 23, 2015

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