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

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 gel	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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: Tretinoin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.

Enrollment:	83
Study Start Date:	February 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Clindamycin/Tretinoin Gel Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, chin, cheeks) once daily at night for 12 weeks	Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks Other Name: Ziana
Placebo Comparator: Placebo gel Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks.	Drug: Placebo gel Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks Other Name: placebo

Detailed Description:

Currently, there is no known cure for rosacea. The most effective treatment is systemic antibiotics, particularly of the tetracycline family. Topical treatments include metronidazole, antibacterials such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. Isotretinoin (Accutane) is also used.

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
Stanford, California, United States, 94305
United States, Massachusetts
CURTIS - Massachussetts General Hospital
Boston, Massachusetts, United States, 02114

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chang AL, Alora-Palli M, Lima XT, Chang TC, Cheng C, Chung CM, Amir O, Kimball AB. A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks. J Drugs Dermatol. 2012 Mar;11(3):333-9.

Responsible Party:	Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00823901 History of Changes
Other Study ID Numbers:	2008-P-001828
Study First Received:	January 14, 2009
Results First Received:	April 4, 2011
Last Updated:	June 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

rosacea
clindamycin
tretinoin
clinical study
treatment

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Clindamycin
Clindamycin-2-phosphate
Tretinoin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013