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

The Dermatology Centre, Calgary, Alberta T2S 3B3, Canada; Recruiting
Kirk Barber, MD, Phone: 403-299-5838, Email: arjuni@shaw.ca
Kirk Barber, MD, Principal Investigator

Stratica Medical, Edmonton, Alberta T5K 1X3, Canada; Recruiting
Norman Wasel, MD, Phone: 780-428-5554, Email: nwasel@shaw.ca
Norman Wasel, MD, Principal Investigator

Scott Dinehart, Little Rock, Arkansas 72205, United States; Recruiting
Scott Dinehart, MD, Phone: 501-227-8422, Email: bettydavis01@sbcglobal.net
Scott Dinehart, MD, Principal Investigator

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States; Recruiting
Dow Stough, MD, Phone: 501-620-4449, Email: tdugan@burkepharmaceutical.com
Dow Stough, MD, Principal Investigator

Guildford Dermatology Specialists, Surrey, British Columbia T3A2N1, Canada; Recruiting
Lorne Albrecht, Phone: 604-585-1110, Email: julie@dermis.ca
Lorne Albrecht, MD, Principal Investigator

Dermatology and Laser Center, Marina Del Rey, California 90292, United States; Recruiting
Marcia Glenn, MD, Phone: 310-821-7658, Email: odysseymedspa@aol.com
Marcia Glenn, MD, Principal Investigator

Solano Clinical Research, Vallejo, California 94589, United States; Recruiting
Serena Mraz, MD, Phone: 707-643-5785, Email: crector@downpharmsci.com
Serena Mraz, MD, Principal Investigator

Therapeutics Clinical Research, San Diego, California 92123, United States; Recruiting
Stacy Smith, MD, Phone: 858-571-6800, Ext: 148, Email: mlvawter@therapeuticsresearch.com
Stacy Smith, MD, Principal Investigator

Longmont Clinic, Longmont, Colorado 80501, United States; Recruiting
Scott Clark, MD, Phone: 303-776-8718, Email: lmcclure@lmrn.com
Scott Clark, MD, Principal Investigator

Colorado Medical Research Center, Denver, Colorado 80210, United States; Recruiting
James Swinehart, MD, Phone: 303-744-7000, Email: cmrc@pcisys.net
James Swinehart, MD, Principal Investigator

International Dermatology Research, Inc., Miami, Florida 33144, United States; Recruiting
Alicia Barba, MD, Phone: 305-225-0400, Email: info@intldermaresearch.com
Alicia Barba, MD, Principal Investigator

Advanced Dermatology, Clermont, Florida 34711, United States; Recruiting
Michael Bond, MD, Phone: 352-241-4298, Email: bondresearch@leavittmgt.com
Michael Bond, MD, Principal Investigator

Anne M. Loebl, Augusta, Georgia 30904, United States; Recruiting
Anne M Loebl, MD, Phone: 706-729-9966, Email: annemloebl@comcast.net
Anne M Loebl, MD, Principal Investigator

Scott Glazer, Buffalo Grove, Illinois 60089, United States; Recruiting
Scott Glazer, MD, Phone: 847-459-6611, Email: bcarrick1201@yahoo.com
Scott Glazer, MD, Principal Investigator

Sound Bend Clinic, South Bend, Indiana 46617, United States; Recruiting
Holly H Harris, MD, Phone: 574-237-9391, Email: iege@southbendclinic.com
Holly H. Harris, MD, Principal Investigator

Dermadvance Research, Winnipeg, Manitoba R3C 1R4, Canada; Recruiting
John O'Toole, MD, Phone: 204-947-1630, Email: dermres@mts.net
John O'Toole, MD, Principal Investigator

Hamzavi Dermatology, Port Huron, Michigan 48060, United States; Recruiting
Ilefat Hamzavi, MD, Phone: 810-985-5769, Email: skading@hamzavi.com
Ilefat Hamzavi, MD, Principal Investigator

Central Dermatology, PC, St. Louis, Missouri 63117, United States; Recruiting
Craig Leonardi, MD, Phone: 314-721-5565, Email: lindad@centralderm.com
Graig Leonardi, MD, Principal Investigator

Darmouth-Hitchcock Medical Center Section of Dermatology, Lebanon, New Hampshire 03756, United States; Recruiting
James Dinulos, MD, Phone: 603-653-9418, Email: james.g.dinulos@Hitchcock.org
James Dinulos, MD, Principal Investigator

Academic Dermatology, Albuquerque, New Mexico 87106, United States; Recruiting
Alicia Bucko, DO, Phone: 505-247-4220, Email: eatschen@aol.com
Alicia Bucko, DO, Principal Investigator

Elizabeth Arthur, Rochester, New York 14609, United States; Recruiting
Elizabeth Arthur, Phone: 585-266-5420, Email: jtantalo@frontiernet.net
Elizabeth Arthur, MD, Principal Investigator

Derm Research Center of New York, Stony Brook, New York 11790, United States; Recruiting
Elyse Rafal, MD, Phone: 631-689-0300, Email: scarpenter@drcny.com
Elyse Rafal, MD, Principal Investigator

Nexus Clinical Research, St. Johns, Newfoundland and Labrador A1B 3E1, Canada; Recruiting
Ian Landells, MD, Phone: 709-726-3386, Email: thaines@nexusresearch.com
Ian Landells, MD, Principal Investigator

Unifour Medical Research Associates, Hickory, North Carolina 28601, United States; Recruiting
George Fisher, MD, Phone: 828-345-5060, Email: amccary@piedmontmedical.com
George Fisher, MD, Principal Investigator

Haber Dermatology & Cosmetic Research, South Euclid, Ohio 44118, United States; Recruiting
Robert Haber, MD, Phone: 216-932-5200, Email: haberresearch@gmail.com
Robert Haber, MD, Principal Investigator

OU Health Sciences Center-Dept. of Dermatology, Oklahoma City, Oklahoma 73104, United States; Recruiting
Raymond Cornelison, MD, Phone: 405-271-5839, Email: Ray-cornelison@ouhs.edu
Raymond Cornelison, MD, Principal Investigator

Lynderm Research, Inc., Markham, Ontario L3P 6L2, Canada; Recruiting
Charles Lynde, MD, Phone: 905-471-8011, Email: barbara@lynderm.com
Charles Lynde, MD, Principal Investigator

K. Papp Clinical Research, Inc., Waterloo, Ontario N2J 1C4, Canada; Recruiting
Kim Papp, MD, Phone: 519-579-9535, Email: kpapp@probitymedical.com
Kim Papp, MD, Principal Investigator

Oregon Medical Center, PC, Portland, Oregon 97223, United States; Recruiting
Robert Matheson, MD, Phone: 503-245-1525, Email: ormedresearch@aol.com
Robert Matheson, MD, Principal Investigator

Rivergate Dermatology, Goodlettsville, Tennessee 37072, United States; Recruiting
Keith Loven, MD, Phone: 615-859-7546, Email: pwasher@rivderm.com
Keith Loven, MD, Principal Investigator

DermResearch, Inc., Austin, Texas 78759, United States; Recruiting
Michael Jarratt, MD, Phone: 512-349-9889, Email: rrodriquez@dermresearch.com
Michael Jarratt, MD, Principal Investigator

Progressive Clinical Research, San Antonio, Texas 78229, United States; Recruiting
Mark S Lee, MD, Phone: 210-614-5557, Email: chernandez@progclin.com
Mark S Lee, MD, Principal Investigator

Center for Clinical Studies, Houston, Texas 77058, United States; Recruiting
Stephen Tyring, MD, Phone: 281-333-2288, Email: cingram@ccstexas.com
Stephen Tyring, MD, Principal Investigator

Virginia Clinical Research, Inc., Norfolk, Virginia 23507, United States; Recruiting
David Pariser, MD, Phone: 757-625-0151, Email: bheroux@vcrinc.org
David Pariser, MD, Principal Investigator

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