Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel (Drug); Placebo gel (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Alexa Kimball, MD, MPH, Principal Investigator, Affiliation: Massachusetts General Hospital
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Change in Number of Inflammatory Lesions From Baseline to Week 12
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subjects 18 years of age and older.
2. Clinical diagnosis of papulopustular facial rosacea.
3. A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus
pustules).
4. Willing and able to understand and sign informed consent.
5. Able to complete study and comply with study procedures.
Exclusion Criteria:
1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
or severe acne requiring systemic treatment.
2. 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.
3. Use of topical rosacea treatments in the past 2 weeks.
4. Use of systemic antibiotics in the past 4 weeks.
5. Use of systemic retinoids within the past 3 months.
6. Use of laser or light based rosacea treatments within the past 2 months.
7. Concomitant use of medications that are reported to exacerbate rosacea, such as
topical and systemic steroids as these may impact assessments.
8. Current drug or alcohol abuse.
9. 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.
10. 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.
11. Subjects who are pregnant or planning a pregnancy.
12. Use of any investigational therapy within the past 4 weeks.
13. Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
Locations and Contacts
Department of Dermatology - Stanford School of Medicine, Stanford, California 94305, United States
CURTIS - Massachussetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Related 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. 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. 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.
Starting date: February 2009
Last updated: June 19, 2012
|
