Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

Condition(s) targeted: Acne Vulgaris

Intervention: clindamycin / benzoyl peroxide gel (Drug); clindamycin gel (Drug); BPO gel (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 Laboratories

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris

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

Primary outcome: Acne lesion counts and Investigator's Static Global Assessment (ISGA).

Secondary outcome: Local tolerability and adverse events

Detailed description: A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1: 1:1: 1 ratio (clindamycin / benzoyl peroxide gel: clindamycin gel: BPO gel: vehicle gel).

Minimum age: 12 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Be 12 to 45 years of age, inclusive, and in good general health.

- Clinical diagnosis of acne vulgaris

- Females of childbearing potential participating in the study must agree to use a

medically acceptable method of contraception while receiving protocol-assigned product.

- Have the ability and willingness to follow all study procedures, attend all scheduled

visits, and successfully complete the study.

- Have the ability to understand and sign a written informed consent form, which must be

completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

Exclusion Criteria:

- Are pregnant or breast-feeding.

- Have a history or presence of other conditions that may increase the risk of the

subject participating in the study and/or affect the evaluated outcomes.

- Used topical antibiotics on the face or used systemic antibiotics within the past 2

weeks.

- Used topical corticosteroids on the face or systemic corticosteroids within the past 4

weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.

- Used systemic retinoids within the past 6 months or topical retinoids within the past

6 weeks.

- Received treatment with estrogens (including oral, implanted, injected and topical

contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.

- Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates,

etc.) within the past 2 weeks.

- Used abradents or facial procedures, within the past 2 weeks.

- Use medications that may exacerbate acne.

- Have a known hypersensitivity or have had previous allergic reaction to any of the

active components, lincomycin, or excipients of the study product.

- Used any investigational therapy within the past 4 weeks, or currently participating

in another clinical study.

Dermatology and Skin Care Center FXM Research International, Belize City, Belize; Recruiting
Maria Ambros, Phone: 305-220-5222, Email: info@fxmresearch.com
Julitta Bradley, MD, Principal Investigator

Dr. Moguel's Clinic/FXM Research International, Belize City, Belize; Recruiting
Paulina Torres, Phone: 305-220-5222, Email: info@fxmresearch.com
Ines Mendez-Moguel, MD, Principal Investigator

Nexus Clinical Research, St. John's NL A1B 3E1, Canada; Recruiting
Tina Pretty-Haines, RN, Phone: 709-726-3386, Email: thaines@nexusresearch.com
Ian Landells, MD, Principal Investigator

CRDQ Centre de Recherche Dermatologique du Quebec, Quebec G1V 4X7, Canada; Recruiting
Helene Lacroix, Phone: 418-650-2339, Email: crdg@bellnet.ca
Yves Poulin, MD, Principal Investigator

Guildford Dermatology Specialist, Surrey, British Columbia V3R6A7, Canada; Not yet recruiting
Theresa Flinn, RN, Phone: 604-585-9746, Email: theresa@dermis.ca
Lorne Albrecht, MD, Principal Investigator

Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology, San Diego, California 92123, United States; Recruiting
Nikola Borok, CCRC, Phone: 858-576-1700, Ext: 4295, Email: nborok@rchsd.org
Lawrence Eichenfield, MD, Principal Investigator

The Laser Institute for Dermatology, Santa Monica, California 90404, United States; Recruiting
Erin Haight, RN, SC, Phone: 310-828-2282, Ext: 109
Ava Shamban, MD, Principal Investigator

Cherry Creek Research, Inc., Denver, Colorado 80209, United States; Recruiting
John Bradt, Phone: 303-388-5629, Email: ccdresearch@qwest.net
Michael J Maloney, MD, Principal Investigator

University of Miami Cosmetic Medicine and Research Institute, Miami Beach, Florida 33140, United States; Recruiting
Michaela Bell, Phone: 305-531-5788, Email: mbell@med.miami.edu
Leslie Baumann, MD, Principal Investigator

Skin Care Research, Inc., Boca Raton, Florida 33486, United States; Recruiting
Lina Cardona, Phone: 561-750-0544, Email: l_cardona@comcast.net
Marta Rendon, MD, Principal Investigator

FXM Research, Miami, Florida 33175, United States; Recruiting
Francisco Moncada, RN, CCRC, Phone: 305-220-5222, Email: francisco.moncada@fxmresearch.com
Hector Wiltz, MD, Principal Investigator

Atlanta Dermatology & Vein Research Center, LLC, Alpharetta, Georgia 30022, United States; Recruiting
Wan Huang, Phone: 770-360-8881, Email: whuang@dermandvein.com
Tiffani Hamilton, MD, Principal Investigator

SKINQRI, Lincolnshire, Illinois 60069, United States; Recruiting
Erin DeVita, CCRC, Phone: 847-419-9100
Amy Taub, MD, Principal Investigator

Dawes Fretzin Clinical Research Group, Indianapolis, Indiana 46260, United States; Recruiting
Erin Thomas, Phone: 317-621-7731, Ext: 123, Email: ethomas@ecommunity.com
Scott Fretzin, MD, Principal Investigator

DermResearch, PLLC, Louisville, Kentucky 40217, United States; Recruiting
Christina Kiten, Phone: 502-451-9000, Email: wedoderm@bellsouth.net
Leon H Kircik, MD, Principal Investigator

Somerset Skin Centre, Troy, Michigan 48084, United States; Recruiting
Dianna Fortunato, Phone: 248-244-8448, Email: dianna@somersetskincentre.com
George J Murakawa, MD, Principal Investigator

DermResearch Center of New York, Stony Brook, New York 11790, United States; Recruiting
Ruth Verspoor, Phone: 631-689-1900, Email: rverspoor@drcny.com
Elyse S Rafal, MD, Principal Investigator

Dermatology Associates of Rochester, PC, Rochester, New York 14623, United States; Recruiting
Denise Forster, LPN, CCRC, Phone: 585-272-0700, Email: dforster@skinsearch.org
John H Tu, MD, Principal Investigator

Lynderm Research, Inc., Markham, Ontario L3P 1A8, Canada; Recruiting
Susan Jones, Phone: 905-471-8011, Email: susan@lynderma.com
Charles Lynde, MD, Principal Investigator

North Bay Dermatology Centre, North Bay, Ontario P1B3Z7, Canada; Not yet recruiting
Suzanne Gervais, Phone: 705-476-2629, Email: sugervais@cogeco.ca
Les Rosoph, MD, Principal Investigator

Dermatrial Research, Hamilton, Ontario L8N 1V6, Canada; Recruiting
Laura MacDonald, Phone: 905-524-0012, Email: laura@dermatrials.com
Ronald Vender, MD, Principal Investigator

The Skin Wellness Center, PC, Knoxville, Tennessee 37922, United States; Recruiting
Jennifer Butcher, Phone: 865-251-9963
Kimberly Grande, MD, Principal Investigator

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

Arlington Center for Dermatology, Arlington, Texas 76011, United States; Recruiting
Hope Villegas, Phone: 817-795-7546
Angela Moore, MD, Principal Investigator

Starting date: October 2008
Ending date: November 2009
Last updated: December 10, 2008