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

This study has been completed.

First Received: February 27, 2007 Last Updated: August 5, 2008 History of Changes

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00441415

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Adapalene BPO	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
Global severity assessment at each post Baseline visit

Enrollment:	272
Study Start Date:	February 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441415

Locations

United States, California
Paul YAMAUCHI
Santa Monica, California, United States, 90404
United States, Minnesota
Steven E. KEMPERS
Fridley, Minnesota, United States, 55432
United States, New Mexico
Dr Alicia BUCKO
Albuquerque, New Mexico, United States, 87106
United States, New York
Elisabeth ARTHUR
Rochester, New York, United States, 14609

Sponsors and Collaborators

Galderma

Investigators

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	RD.03.SPR.29058
Study First Received:	February 27, 2007
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00441415 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: Ministry of Health; Spain: Ministry of Health

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Benzoyl Peroxide
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Sensory System Agents

Acneiform Eruptions
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010