NCT01517893

Clinical Trial of Simvastatin to Treat Generalized Vitiligo

A Phase-II, Randomized, Placebo-controlled Trial of Simvastatin in Generalized Vitiligo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: John Harris · Academic / Other
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Simvastatin	Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
DRUG	Placebo	Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2012-01-25
• Last updated: 2018-11-14
• Results posted: 2015-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study