Full Text View
Tabular View
No Study Results Posted
Related Studies
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called W0265 Gel
This study has been completed.
First Received: May 24, 2008   Last Updated: June 8, 2009   History of Changes
Sponsor: Stiefel, a GSK Company
Information provided by: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT00689117
  Purpose

The purpose of this study is to demonstrate the safety and effectiveness of W0265 gel in subjects with acne vulgaris. The hypothesis is that W0265 is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.


Condition Intervention Phase
Acne Vulgaris
Acne
Drug: W0265 Gel
Drug: Clindamycin Gel (clindamycin )
Drug: Tretinoin Gel (tretinoin)
Drug: Vehicle Gel
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of W0265 in Subjects With Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Stiefel, a GSK Company:

Primary Outcome Measures:
  • Co-Primary Endpoints:The absolute change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12.; the proportion of subjects who have a minimum two grade improvement in ISGA score from baseline to week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percent (%) change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have a SGA score of 0 or 1 at week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 1656
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
W0265 Gel
Drug: W0265 Gel
Once daily in the evening for 12 weeks
2: Active Comparator
Clindamycin Gel (clindamycin)
Drug: Clindamycin Gel (clindamycin )
once daily in the evening for 12 weeks
3: Active Comparator
Tretinoin Gel (tretinoin)
Drug: Tretinoin Gel (tretinoin)
Once daily in the evening for 12 weeks
4: Placebo Comparator
Vehicle Gel
Drug: Vehicle Gel
Once daily in the evening for 12 weeks

Detailed Description:

W0265 gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 12 years of age or older in good general health
  • ISGA score of 2 or greater at Baseline

Exclusion Criteria:

  • Any nodulo-cystic lesions at Baseline
  • Pregnancy or breast feeding
  • History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
  • Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
  • Use of topical anti-acne medications within the past 2 weeks.
  • Use of topical or systemic antibiotics on the face within the past 2 weeks.
  • Use of topical or systemic corticosteroids within the past 2 weeks.
  • Use of systemic retinoids within the past 3 months.
  • Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.
  • Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
  • Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
  • Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
  • Concomitant use of tanning booths or sunbathing.
  • Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product
  • A significant medical history of or are currently immunocompromised
  • Current drug or alcohol abuse. (Drug screening not required.)
  • Use of any investigational therapy within 4 weeks of enrollment.
  • Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689117

  Hide Study Locations
Locations
United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 33608
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
University Clinical Trials
San Diego, California, United States, 92103
Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, United States, 94538
United States, Colorado
Longmont Medical Research Network
Longmont, Colorado, United States, 80501
United States, Florida
FXM Research Corporation
Miami, Florida, United States, 33175
Advanced Dermatolgy & Cosemtic Surgery
Ormond Beach, Florida, United States, 32174
FXM Research - Miramar
Miramar, Florida, United States, 33027
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Nebraska
Skin Specialists, P.C.
Omaha, Nebraska, United States, 68144
United States, New Mexico
Academic Dermatology Research
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Dermatology Research Associates, Inc.
Cincinnati, Ohio, United States, 45230
United States, Pennsylvania
Yardley Dermatology Associates
Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Tennessee
Tennessee Clinical Research
Nashville, Tennessee, United States, 37215
Dermatology Associates of Knoxville, P.C.
Knoxville, Tennessee, United States, 37934
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
College Station, Texas, United States, 77840
The Hair and Skin Research Treatment Center
Dallas, Texas, United States, 75246
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124
United States, Washington
Premier Clincial Research
Spokane, Washington, United States, 99204
United States, Wisconsin
Advanced Healthcare
Milwaukee, Wisconsin, United States, 53209
Belize
Dermatology And Skin Centre
Belize City, Belize
Dr. Moguel's Clinic
Belize City, Belize
Canada, Ontario
K. Papp Clinical Research, Inc.
Waterloo, Ontario, Canada, N2J 1C4
Windsor Clinical Research Center, Inc.
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research, Inc.
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Stiefel, a GSK Company
Investigators
Study Director: David A. Angulo, MD Stiefel Labortories, Inc.
  More Information

No publications provided

Responsible Party: Stiefel Laboratories, Inc. ( Jason Mann, Director, Global Clinical Operations )
Study ID Numbers: W0265-03
Study First Received: May 24, 2008
Last Updated: June 8, 2009
ClinicalTrials.gov Identifier: NCT00689117     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Stiefel, a GSK Company:
Acne Vulgaris
Acne

Additional relevant MeSH terms:
Anti-Infective Agents
Clindamycin
Facial Dermatoses
Skin Diseases
Clindamycin-2-phosphate
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions
Keratolytic Agents
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Acneiform Eruptions
Therapeutic Uses
Tretinoin
Dermatologic Agents

ClinicalTrials.gov processed this record on November 27, 2009