Clinical Trial of Simvastatin to Treat Generalized Vitiligo

John Harris

Status and phase

Completed

Phase 2

Conditions

Vitiligo

Treatments

Drug: Simvastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01517893

UM-DERM001

Details and patient eligibility

About

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.

Full 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 signaling by blocking activation of STAT12 and prevented and reversed disease in our mouse model.3 A case report described a patient with vitiligo who repigmented with simvastatin.4 We conducted a small, randomized, double-blind, placebo-controlled, phase II clinical trial to test simvastatin as a treatment for vitiligo. After obtaining informed consent, we enrolled men ages 18 to 64 years with vitiligo affecting 3% to 50% of their body surface area (BSA). We excluded patients with a segmental presentation; those already taking 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor; those with existing thyroid disease; and women, based on their increased risk of simvastatin-induced myopathy.

Enrollment

15 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.