Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
Information source: Stiefel Laboratories
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Benzoyl peroxide/clindamycin gel + tazarotene cream (Drug); Benzoyl peroxide/clindamycin gel + vehicle cream (Drug); Benzoyl peroxide gel + tazarotene cream (Drug); Clindamycin gel + tazarotene cream (Drug); Vehicle gel+ tazarotene cream (Drug); Vehicle gel + vehicle cream (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Stiefel Laboratories Official(s) and/or principal investigator(s):
David G Angulo, MD, Study Director, Affiliation: Sr. Director Global Clinical Research, Stiefel Laboratories, Inc.
Summary
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative
for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a
combination product including these actives for the treatment of acne vulgaris.
You may be suitable to take part in this study because you have acne vulgaris on your face.
Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,
legs, and back.
Clinical Details
Official title: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The absolute change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12.
The proportion of subjects who have a minimum 2-grade improvement in ISGA score from baseline to week 12.
Secondary outcome: The percent (%) change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12.
The proportion of subjects who have an ISGA score of 0 or 1 at week 12.
Detailed description:
The study subjects must have acne vulgaris and will apply study drug to their face for 12
weeks.
Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be
assessed at every visit to determine how the study drug is working. Safety will be assessed
by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals
from the study.
Eligibility
Minimum age: 12 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
- Subjects must have acne on their face.
- Female subjects of childbearing potential must have a negative pregnancy test. If
sexually active, one medically acceptable forms of contraception must be practiced
from baseline to the last study visit.
- Subjects must have the ability and willingness to follow all study procedures, attend
all scheduled visits, and successfully complete the study.
- Subjects must be capable of understanding and willing to provide signed and dated
written voluntary informed consent (and any local or national authorization
requirements).
- Subjects must be able to complete the study and to comply with study instructions.
Exclusion Criteria:
- Subjects who are pregnant, trying to become pregnant, or breast-feeding.
- Subjects with conditions that may influence the safety and or efficacy assessments of
the study including, but not limited to: regional enteritis or inflammatory bowel
disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis,
or perioral dermatitis, subject who are immunocompromised or have had any major
illness within 30 days before the screening examination
- History of known or suspected intolerance including any known hypersensitivity or
previous allergic reaction to any of the ingredients of the study products
- Subjects who have used topical antibiotics or topical steroids on the face, facial
procedures, or any investigational therapy within the past 4 weeks or systemic
retinoids within the past 6 months.
- Subjects who have any other disease or condition, or are using any medication, that in
the judgment of the investigator would put the subject at unacceptable risk for
participation in the study.
- Other exclusion criteria may apply.
Locations and Contacts
Dermatology Research of Arkansas, Little Rock, Arkansas 72205, United States; Recruiting
Betty Davis, Phone: 501-227-8422, Ext: 21
Scott Dinehart, MD, Principal Investigator
Center for Dermatology Cosmetic and Laser Surgery, Fremont, California 94538, United States; Recruiting
Cindy Epps, Phone: 510-797-4111, Ext: 216
Sunil Dhawan, MD, Principal Investigator
Center for Dermatology and Laser Surgery, Sacramento, California 95819, United States; Recruiting
Regan Johnson, Phone: 916-454-5922
Emil Tanghetti, MD, Principal Investigator
Boulder Medical Center, P.C., Boulder, Colorado 80304, United States; Recruiting
Rindy Dahlen, Phone: 303-440-3046
Steven Hong, MD, Principal Investigator
Dermatology Associates Research, Coral Gables, Florida 33134, United States; Recruiting
Luz Marin, Phone: 305-567-1930
David Rodriquez, MD, Principal Investigator
MedaPhase, Inc., Newnan, Georgia 30263, United States; Recruiting
Karen Mangieri, Phone: 770-252-6900
Mark Ling, MD, Principal Investigator
Callender Center for Clinical Research, Mitchellville, Maryland 20721, United States; Recruiting
Kymberly Valentine, Phone: 301-249-0970
Valerie Callender, MD, Principal Investigator
Grekin Skin Institute, Warren, Michigan 48088, United States; Recruiting
Jennifer Meitzner, Phone: 586-759-5525
Steve Grekin, MD, Principal Investigator
Dermatology Consulting Services, High Point, North Carolina 27262, United States; Recruiting
Tina Hatch, CCRC, Phone: 336-841-1411
Zoe Draelos, MD, Principal Investigator
University of North Carolina Chapel Hill, Chapel Hill, North Carolina 27599, United States; Not yet recruiting
Erika Hanami, Phone: 919-843-5126, Email: erika_hanami@med.unc.edu
Aida Lugo, MD, Principal Investigator
MS Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Not yet recruiting
Silvia Gosik, Phone: 717-531-1513, Email: sgosik@psu.edu
Andrea Zaenglein, MD, Principal Investigator
The Skin Wellness Center, PC, Knoxville, Tennessee 37922, United States; Recruiting
Kim Gateman, LPN, Phone: 865-251-9963
Kimberly Grande, MD, Principal Investigator
Rivergate Dermatology & Skin Care Center, Goodlettsville, Tennessee 37072, United States; Recruiting
Peggy Washer, Phone: 615-859-0900
Keith Loven, MD, Principal Investigator
Dermatology Treatment & Research Center, Dallas, Texas 75230, United States; Recruiting
Charles Kundig, Phone: 972-661-2729, Ext: 229
William Abramovits, MD, Principal Investigator
Suzanne Bruce and Associates, PA, Houston, Texas 77056, United States; Recruiting
Sandy Nero, Phone: 713-850-0240, Ext: 112
Suzanne Bruce, MD, Principal Investigator
Dermatology Clinical Research Center of San Antonio, San Antonio, Texas 78229, United States; Recruiting
Glennda Bruce, Phone: 210-692-1382
Steven A. Davis, MD, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: March 2009
Last updated: September 18, 2008
|
