Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Medicis Pharmaceutical Corporation
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00823901

Purpose

The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.

Condition	Intervention	Phase
Rosacea	Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel Drug: placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Pilot Study to Determine the Safety and Efficacy of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel For The Treatment of Rosacea Over 12 Weeks

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Tretinoin

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

The absolute change in inflammatory lesion counts (papules and pustules) from baseline to week 12 (end of treatment). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in transient erythema (flushing) at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Clindamycin/Tretinoin Gel: Experimental Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel	Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel apply to the face at bed time
2: Placebo Comparator	Drug: placebo placebo gel - apply to face at bedtime

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects 18 years of age and older.
Clinical diagnosis of papulopustular facial rosacea.
A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules).
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures.

Exclusion Criteria:

Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms.
Use of topical rosacea treatments in the past 2 weeks.
Use of systemic antibiotics in the past 4 weeks.
Use of systemic retinoids within the past 3 months.
Use of laser or light based rosacea treatments within the past 2 months.
Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments.
Current drug or alcohol abuse.
Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris.
Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Subjects who are pregnant or planning a pregnancy.
Use of any investigational therapy within the past 4 weeks.
Known hypersensitivity or previous allergic reaction to clindamycin or retinoids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823901

Locations

United States, California
Department of Dermatology - Stanford School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Emily S Gorell 650-725-4302 egorell@stanford.edu
Principal Investigator: Alfred Land, MD
Sub-Investigator: Anne L Chang, MD
United States, Massachusetts
CURTIS - Massachussetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexandra B Kimball, MD 617-726-5066 harvardskinstudies@partners.org
Principal Investigator: Alexandra B Kimball, MD, MPH
Sub-Investigator: Maria B Alora-Palli, MD

Sponsors and Collaborators

Massachusetts General Hospital

Medicis Pharmaceutical Corporation

Investigators

Principal Investigator:

Alexa Kimball, MD, MPH

Massachusetts General Hospital

More Information

Publications:

Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. Review.

Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. No abstract available.

Wilkin J, Dahl M, Detmar M, Drake L, Feinstein A, Odom R, Powell F. Standard classification of rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002 Apr;46(4):584-7. No abstract available.

Wilkin JK, DeWitt S. Treatment of rosacea: topical clindamycin versus oral tetracycline. Int J Dermatol. 1993 Jan;32(1):65-7.

Diaz BV, Lenoir MC, Ladoux A, Frelin C, Démarchez M, Michel S. Regulation of vascular endothelial growth factor expression in human keratinocytes by retinoids. J Biol Chem. 2000 Jan 7;275(1):642-50.

Responsible Party:	Massachusetts General Hospital ( Alexandra B. Kimball, MD, MPH )
Study ID Numbers:	2008-P-001828
Study First Received:	January 14, 2009
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00823901 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

rosacea
clindamycin
tretinoin
clinical study
treatment

Additional relevant MeSH terms:

Anti-Infective Agents
Clindamycin
Skin Diseases
Clindamycin-2-phosphate
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Pharmacologic Actions

Keratolytic Agents
Rosacea
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Therapeutic Uses
Tretinoin
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010