Status:
COMPLETED
Clinical Trial of Simvastatin to Treat Generalized Vitiligo
Lead Sponsor:
John Harris
Conditions:
Vitiligo
Eligibility:
MALE
18-64 years
Phase:
PHASE2
Brief Summary
The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new treatment for viti...
Detailed Description
Vitiligo is an autoimmune disease caused by autoreactive CD8+ T lymphocytes that target melanocytes, and interferon-γ-induced CXCL10 plays an important role.1 Simvastatin inhibits interferon-γ signali...
Eligibility Criteria
Inclusion
- male gender
- ages 18-64
- at least one vitiligo skin lesion measuring at least 2x2 cm in size
- willing and able to understand and sign informed consent
- able to complete study and comply with study procedures
Exclusion
- history of segmental vitiligo
- allergy to statin medications
- use of statin medications due to cardiac risks.
- use of any medications contraindicated with use of simvastatin
- use of topical vitiligo treatments in past 4 weeks
- use of laser or light-based vitiligo treatments within the past 8 weeks
- treatment with immunomodulating oral medications in the past 4 weeks
- use of statin medications in the past 8 weeks
- evidence of hepatic dysfunction, personal or family history of non-alcoholic steatotic hepatitis, or personal history of hepatitis
- evidence of renal dysfunction
- history of myopathy or rhabdomyolysis, or elevated baseline creatinine kinase
- recent history of alcohol or drug abuse
- history of diabetes
- untreated hypothyroidism
- other conditions that require the use of interfering topical or systemic therapy
- other current conditions that might interfere with study assessments such as, but not limited to, atopic dermatitis and psoriasis
- clinically significant abnormal findings or conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01517893
Start Date
January 1 2012
End Date
December 1 2014
Last Update
November 14 2018
Active Locations (1)
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1
University of Massachusetts Medical School Clinical Research Center
Worcester, Massachusetts, United States, 01655