Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

Condition(s) targeted: Acne Vulgaris

Intervention: Adapalene (Drug); Vehicle (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Galderma

Overall contact:
Kathleen Smith, Phone: 707-793-2600, Email: ksmith@dowpharmsci.com

The purpose of this study is to determine whether Adapalene, 0. 1% is safe and effective in the treatment of Acne Vulgaris.

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

Primary outcome: Percent of subjects who have at least a 2 point reduction at week 12 in the IGA score from baseline, and absolute change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts.

Secondary outcome: Percent change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts.

Detailed description: This study will compare the efficacy and safety of Adapalene, 0. 1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1: 1 ratio to Adapalene, 0. 1% or Vehicle.

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

Criteria:

Inclusion Criteria:

- Subjects with Moderate or Severe Acne Vulgaris,

- 20-50 papules and pustules in total on the face excluding the nose

- 30-100 non-inflammatory lesions on the face excluding the nose.

- Negative urine pregnancy test for all females.

Exclusion Criteria:

- Subjects with more than one acne nodule.

- Subjects with any acne cyst on the face.

- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced

acne, etc.), or severe acne requiring systemic treatment.

- Subjects with underlying diseases or other dermatologic conditions that require the

use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.

- Subjects who are pregnant, nursing, or planning a pregnancy.

Kathleen Smith, Phone: 707-793-2600, Email: ksmith@dowpharmsci.com

Dermatology Associates, Calgary, Alberta T3A 2N1, Canada; Recruiting
Derek Woolner, MD, Phone: 403-284-4222, Email: lois@dermdocs.net
Derek Woolner, MD, Principal Investigator

Derm Research @ 888 Inc, Vancouver, British Columbia V5Z 3Y1, Canada; Recruiting
Richard Thomas, MD, Phone: 604-873-4049, Email: trials@dermatologyresearch.com
Richard Thomas, MD, Principal Investigator

University of California, San Diego, California 92123, United States; Recruiting
Lawrence Eichenfield, MD, Phone: 858-576-1700, Ext: 4295
Lawrence Eichenfield, MD, Principal Investigator

Dermatology Specialists, Inc., Vista, California 92083, United States; Recruiting
Darryl Wong, MD, Phone: 760-724-7171, Email: research2@dermspec.com
Darryl Wong, MD, Principal Investigator

Cherry Creek Dermatology, Denver, Colorado 80246, United States; Recruiting
Michael J Maloney, MD, Phone: 303-388-5629, Ext: 707, Email: ccdresearch@gwest.net
Michael J Maloney, MD, Principal Investigator

Dermatology Research, North Pinellas Park, Florida 33781, United States; Recruiting
Gary Heller, MD, Phone: 727-541-4431, Email: Jennie.feola@gmail.com
Gary Heller, MD, Principal Investigator

Advanced Dermatology and Cosmetic Surgery, Ormond Beach, Florida 32174, United States; Recruiting
James Solomon, MD, Phone: 386-898-0547, Ext: 204, Email: acruz@leavittmgt.com
James Solomon, MD, Principal Investigator

Christie Clinic, PC, Champaign, Illinois 61820, United States; Recruiting
Lester Farhner, MD, Phone: 217-366-1327, Email: Pphillipp@christieclinic.com
Lester Farhner, MD, Principal Investigator

Compliant Clinical Research, Olathe, Kansas 66061, United States; Recruiting
John Proffitt, MD, Phone: 913-481-6415, Email: jslevings@cebridge.net
John Proffitt, MD, Principal Investigator

Dermatology Specialists, Louisville, Kentucky 40202, United States; Recruiting
Joseph Fowler, MD, Phone: 502-583-7546, Email: dermaresearchmhl@msn.com
Joseph Fowler, MD, Principal Investigator

East Coast Clinical Research, Inc., Haverhill, Massachusetts 01830, United States; Recruiting
David Greenstein, MD, Phone: 978-372-7252, Email: eccr2@eccresearch.com
David Greenstein, MD, Principal Investigator

Henry Ford Medical Center-Dept. of Dermatology, Detroit, Michigan 48202, United States; Recruiting
Linda Gold-Stein, MD, Phone: 313-916-1984, Email: mthorn1@hfhs.org
Linda Gold-Stein, MD, Principal Investigator

Midwest Cutaneous Research, Clinton Township, Michigan 48038, United States; Recruiting
Daniel Stewart, MD, Phone: 586-286-7325, Email: probertson@skincareresearch.com
Daniel Stewart, MD, Principal Investigator

Minnesota Clinical Study Centert, Fridley, Minnesota 55432, United States; Recruiting
Steven Kempers, MD, Phone: 763-571-4200, Email: snow@associatedskincare.com
Steven Kempers, MD, Principal Investigator

Skin Specialists, PC, Omaha, Nebraska 68144, United States; Recruiting
Joel Schlessinger, MD, Phone: 402-697-6599, Email: skindoc@lovelyskin.com
Joel Schlessinger, MD, Principal Investigator

Cindy Lamerson, Reno, Nevada 89511, United States; Recruiting
Cindy Lamerson, MD, Phone: 775-827-8100, Email: isnobug@sbcglobal.net
Cindy Lamerson, MD, Principal Investigator

Fran Cook-Bolden, New York, New York 10021, United States; Recruiting
Fran Cook-Bolden, MD, Phone: 212-249-8394, Email: research.cookbolden@gmail.com
Fran Cook-Bolden, MD, Principal Investigator

Dermatology Associates of Rochester, Rochester, New York 14623, United States; Recruiting
Robert Loss, MD, Phone: 585-272-0700, Email: skindar@aol.com
Robert Loss, MD, Principal Investigator

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
Aida Somolinos-Lugo, MD, Phone: 919-843-5126, Email: alugosom@med.unc.edu
Aida Somolinos-Lugo, MD, Principal Investigator

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States; Recruiting
Adnan Nasir, MD, Phone: 919-781-2514, Email: apearch@wakeresearch.com
Adnan Nasir, MD, Principal Investigator

University Dermatology Consultants, Cincinnati, Ohio 45219, United States; Recruiting
Pranav Sheth, MD, Phone: 513-475-7576, Email: vivian.berger@uc.edu
Pranav Sheth, MD, Principal Investigator

Central Sooner Research, Norman, Oklahoma 73069, United States; Recruiting
Paul Gillum, MD, Phone: 405-329-0474, Email: gfletcher@centralsooner.com
Paul Gillum, MD, Principal Investigator

Ultranova Skincare, Barrie, Ontario L4M 6L2, Canada; Recruiting
Rod Kunyetz, MD, Phone: 705-722-4930, Email: kuny@rogers.com
Rod Kunyetz, MD, Principal Investigator

North Bay Dermatology Centre, North Bay, Ontario P1B 3Z7, Canada; Recruiting
Les Rosoph, MD, Phone: 705-476-4539, Email: lesrosoph@hotmail.com
Les Rosoph, MD, Principal Investigator

Northwest Cutaneous Research Specialists, Portland, Oregon 97210, United States; Recruiting
Phoebe Rich, MD, Phone: 503-226-3376, Email: bgseverson@cs.com
Phoebe Rich, MD, Principal Investigator

Siena Medical Research, Montreal, Quebec H3G 1C6, Canada; Recruiting
Wayne Carey, MD, Phone: 514-704-8942, Email: nathalie.morin@much.mcgill.ca
Wayne Carey, MD, Principal Investigator

Palmetto Medical Research, Mount Pleasant, South Carolina 29464, United States; Recruiting
Lesly Davidson, MD, Phone: 843-849-1880, Email: hnelson@piedmontmedical.com
Lesly Davidson, MD, Principal Investigator

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States; Recruiting
Michael Gold, MD, Phone: 615-383-9660, Email: jbiron@goldskincare.com
Michael Gold, MD, Principal Investigator

Dermatology Research Associates, Nashville, Tennessee 37203, United States; Recruiting
David Horowitz, MD, Phone: 615-467-6660, Email: dranash@aol.com
David Horowitz, MD, Principal Investigator

Dermatology Associates, Knoxville, Tennessee 37917, United States; Recruiting
Toivo Rist, MD, Phone: 865-524-2547, Ext: 1136, Email: dermresearch@yahoo.com
Toivo Rist, MD, Principal Investigator

The Center for Skin Research, Houston, Texas 77056, United States; Recruiting
Suzanne Bruce, MD, Principal Investigator

J&S Studies, Inc., Bryan, Texas 77802, United States; Recruiting
Terry Jones, MD, Phone: 979-774-5933, Email: jscott@js-studies.com
Terry Jones, MD, Principal Investigator

Dermatology Research Center, Salt Lake City, Utah 84124, United States; Recruiting
Leonard Swinyer, MD, Phone: 801-269-0135, Email: laura@dermatologyresearch.net
Leonard Swinyer, MD, Principal Investigator

Premier Clinical Research, Spokane, Washington 99204, United States; Recruiting
William Werschler, MD, Phone: 509-879-6887, Email: calexander54@msn.com
William Werschler, MD, Principal Investigator

Starting date: November 2007
Ending date: December 2008
Last updated: September 30, 2008