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Trial record 32 of 233 for:    acne AND Percent

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

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ClinicalTrials.gov Identifier: NCT00441415
Recruitment Status : Completed
First Posted : February 28, 2007
Last Update Posted : August 6, 2008
Sponsor:
Information provided by:
Galderma

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene BPO Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : February 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne




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

Secondary Outcome Measures :
  1. Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
  2. Global severity assessment at each post Baseline visit


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441415


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

Additional Information:
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ClinicalTrials.gov Identifier: NCT00441415     History of Changes
Other Study ID Numbers: RD.03.SPR.29058
First Posted: February 28, 2007    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
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