CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Simvastatin +1 moredrug
Likely dose
Simvastatin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01517893
NCT01517893Phase 2Completed
CompareCT.gov

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

John Harris·interventional·Posted Jan 25, 2012·Updated Nov 14, 2018

In Brief

A Phase 2 clinical trial evaluating Simvastatin and Placebo for Vitiligo. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitiligo
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.4 years ago

Interventions

Simvastatindrug

Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated

Placebodrug

Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated