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:
Galderma
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00441415
First received: February 27, 2007
Last updated: August 5, 2008
Last verified: August 2008
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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:
- 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:
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 Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013