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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.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00441415
First received: February 27, 2007
Last updated: August 5, 2008
Last verified: August 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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:


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:

  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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00441415     History of Changes
Other Study ID Numbers: RD.03.SPR.29058
Study First Received: February 27, 2007
Last Updated: August 5, 2008
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:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Adapalene
Benzoyl Peroxide
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014