Clinical Trial of Simvastatin to Treat Generalized Vitiligo

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

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 vitiligo. The aims of this placebo-controlled study seek to determine the safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients with generalized vitiligo. Additionally, the investigators will collect blood to examine the effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Harris; University of Massachusetts, Worcester
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.