Clinical trial NCT00823901: Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rosacea
Keywords: rosacea
clindamycin
tretinoin
clinical study
treatment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Medicis Pharmaceutical Corporation
First posted: 2009-01-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Mean Change in Number of Inflammatory Lesions From Baseline to Week 12
timeFrame: Baseline, week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Department of Dermatology - Stanford School of Medicine
state: California
city: Boston
country: United States
facility: CURTIS - Massachussetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alexa Kimball, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. doi: 10.1016/j.jaad.2004.03.033.
citation: 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. doi: 10.1016/j.jaad.2004.01.048. No abstract available.
citation: 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. doi: 10.1067/mjd.2002.120625. No abstract available.
citation: Wilkin JK, DeWitt S. Treatment of rosacea: topical clindamycin versus oral tetracycline. Int J Dermatol. 1993 Jan;32(1):65-7. doi: 10.1111/j.1365-4362.1993.tb00974.x.
citation: Diaz BV, Lenoir MC, Ladoux A, Frelin C, Demarchez 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. doi: 10.1074/jbc.275.1.642.
citation: 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.