A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called W0265 Gel

Condition(s) targeted: Acne Vulgaris; Acne

Intervention: W0265 Gel (Drug); Clindamycin Gel (clindamycin ) (Drug); Tretinoin Gel (tretinoin) (Drug); Vehicle Gel (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Stiefel Laboratories

Official(s) and/or principal investigator(s):
David A. Angulo, MD, Study Director, Affiliation: Stiefel Labortories, Inc.

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

The percent (%) change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12.

The proportion of subjects who have a SGA score of 0 or 1 at week 12.

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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Radiant Research, Birmingham, Alabama 35209, United States; Recruiting
Tina Moorer, Phone: 205-870-8803, Ext: 30
Jo Lynne Herzog, MD, Principal Investigator

Coastal Clinical Research, Inc., Mobile, Alabama 33608, United States; Recruiting
Kathy Welch, Phone: 251-414-1984, Ext: 120
Amy Morris, MD, Principal Investigator

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States; Recruiting
Cindy Furr, Phone: 501-620-4449
Dow Stough, MD, Principal Investigator

University Clinical Trials, San Diego, California 92103, United States; Recruiting
Julia Apodaca, Phone: 619-202-0173
Walter Nahm, MD, Principal Investigator

Longmont Medical Research Network, Longmont, Colorado 80501, United States; Recruiting
Pat Zeller, Phone: 303-776-8718
Scott Clark, MD, Principal Investigator

FXM Research Corporation, Miami, Florida 33175, United States; Recruiting
Francisco Moncada, Phone: 305-220-5222
Hector Wiltz, MD, Principal Investigator

Advanced Dermatolgy & Cosemtic Surgery, Ormond Beach, Florida 32174, United States; Recruiting
Yvonne Douglas, Phone: 386-898-0547, Ext: 110
James Solomon, MD, Principal Investigator

Dermatology Specialists, Louisville, Kentucky 40202, United States; Recruiting
Jennifer Walk, Phone: 502-583-7546, Ext: 157
Joseph Fowler, MD, Principal Investigator

Massachusettes General Hospital - Clinical Unit for Research Trials in Skin, Boston, Massachusetts 02114, United States; Recruiting
Xinaida Lima, Phone: 617-726-1660
Alexa Kimball, MD, Principal Investigator

University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Jennifer Keith, Phone: 734-936-4075
Sewon Kang, MD, Principal Investigator

Henry Ford Medical Center, Detroit, Michigan 48202, United States; Recruiting
Karen McKenzie, Phone: 313-916-8847
Linda SteinGold, MD, Principal Investigator

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States; Recruiting
Allie Recruiter, Phone: 763-502-2941
Steven Kempers, MD, Principal Investigator

Skin Specialists, P.C., Omaha, Nebraska 68144, United States; Recruiting
Rhonda Jansen, Phone: 402-697-6599
Joel Schlessinger, MD, Principal Investigator

Dermatology Research Associates, Inc., Cincinnati, Ohio 45230, United States; Recruiting
Amy Foster, Phone: 513-232-3376
Anne Lucky, MD, Principal Investigator

K. Papp Clinical Research, Inc., Waterloo, Ontario N2J 1C4, Canada; Recruiting
Lisa Bennett, Phone: 519-579-9535, Ext: 251
Kim Papp, MD, Principal Investigator

Windsor Clinical Research Center, Inc., Windsor, Ontario N8W 5L7, Canada; Recruiting
Stefanie Soulliere, Phone: 519-971-7693, Ext: 13
Jerry Tan, MD, Principal Investigator

Innovaderm Research, Inc., Montreal, Quebec H2K 4L5, Canada; Recruiting
Nathalie Paisible, Phone: 514-521-4285, Ext: 260
Robert Bissonnette, MD, Principal Investigator

Clinical Partners, LLC, Johnston, Rhode Island 02919, United States; Recruiting
Caroline DiGiulio, Phone: 401-454-3800
Ellen Frankel, MD, Principal Investigator

Tennessee Clinical Research, Nashville, Tennessee 37215, United States; Recruiting
Amy Howell, Phone: 615-383-9660, Ext: 177
Michael Gold, MD, Principal Investigator

Dermatology Associates of Knoxville, P.C., Knoxville, Tennessee 37934, United States; Recruiting
Amy Cross, Phone: 865-524-2547, Ext: 1302
Toivo Rist, MD, Principal Investigator

DermResearch, Inc., Austin, Texas 78759, United States; Recruiting
Poppy Goodin, Phone: 512-349-9889
Michael Jarratt, MD, Principal Investigator

J & S Studies, Inc., College Station, Texas 77840, United States; Recruiting
Carla Clanton, Phone: 979-774-5933
Terry Jones, MD, Principal Investigator

The Hair and Skin Research Treatment Center, Dallas, Texas 75246, United States; Recruiting
Debbie Harlin, Phone: 214-820-4247
David A. Whiting, MD, Principal Investigator

Dermatology Research Center, Inc., Salt Lake City, Utah 84124, United States; Recruiting
Christine Pyne, Phone: 801-269-0135
Leonard Swinyer, MD, Principal Investigator

Premier Clincial Research, Spokane, Washington 99204, United States; Recruiting
Dalyn Boehm, Phone: 509-879-6887
William Werschler, MD, Principal Investigator

Advanced Healthcare, Milwaukee, Wisconsin 53209, United States; Recruiting
Rita Zimmermann, Phone: 414-352-5161, Ext: 4359
Eugene Monroe, MD, Principal Investigator

Starting date: April 2008
Ending date: April 2009
Last updated: September 18, 2008