Clinical Trial of Simvastatin to Treat Generalized Vitiligo - Full Text View

Purpose

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.

Condition	Intervention	Phase
Vitiligo	Drug: Simvastatin Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase-II, Randomized, Placebo-controlled Trial of Simvastatin in Generalized Vitiligo

Resource links provided by NLM:

Genetics Home Reference related topics: vitiligo

MedlinePlus related topics: Vitiligo

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:

Decrease in VASI score [ Time Frame: Assessed at final study visit, 6 months after randomization ] [ Designated as safety issue: No ]
33% decrease in the Vitiligo Area Scoring Index (VASI) from baseline to the last available study visit

Secondary Outcome Measures:

Increase in Investigator's global assessment score [ Time Frame: Assessed at final study visit, 6 months after randomization ] [ Designated as safety issue: No ]
Increase in Investigator Global Assessment Scores of 30% or more from baseline to last available visit
Safety and tolerability of high-dose simvastatin use in vitiligo patients. [ Time Frame: Assessed at every visit following randomization (monthly for 6 months) ] [ Designated as safety issue: Yes ]
Monitoring lab values and patient symptoms for evidence of simvastatin toxicity
Decrease in Sentinel patch area [ Time Frame: Assessed at final study visit, 6 months after randomization ] [ Designated as safety issue: No ]
Decrease in percent depigmentation of sentinel patch lesion from baseline to last available study visit.
Increase in Quality of Life (QoL) Score [ Time Frame: Assessed at final study visit, 6 months after randomization ] [ Designated as safety issue: No ]
Increased quality of life based on end of study questionnaire scores of subjects randomized to treatment with simvastatin versus placebo
Decrease in CXCR3 expression on CD8+ T cells [ Time Frame: Assessed prior to treatment and periodically while on treatment ] [ Designated as safety issue: No ]
Determination of the effects of simvastatin treatment on CXCR3 expression in melanocyte-specific, autoreactive CD8+ T cells in the blood of patients with vitiligo treated with simvastatin versus placebo
Increase in Patient's Global Assessment Score [ Time Frame: Assessed at final study visit, 6 months after randomization ] [ Designated as safety issue: No ]
Increase in Patient's Global Assessment Scores of 30% or more from baseline to last available visit
Correlation among various outcome measures for vitiligo [ Time Frame: Assessed at final study visit, 6 months after randomization ] [ Designated as safety issue: No ]
Comparison of all tested outcome measures to identify the level of correlation among them, including VASI, Sentinel Patch, Investigator's Global Assessment Score, and Patient's Global Assessment Score
Decrease in serum chemokines [ Time Frame: Assessed prior to treatment and periodically while on treatment ] [ Designated as safety issue: No ]
Determination of the effects of simvastatin treatment on multiple chemokines in the blood of patients with vitiligo treated with simvastatin versus placebo

Estimated Enrollment:	50
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intervention arm Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated	Drug: Simvastatin Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
Placebo Comparator: Placebo Arm	Drug: Placebo Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517893

Contacts

Contact: John E. Harris, MD, PhD	508-856-1982	John.Harris@umassmed.edu
Contact: Stefan Vanderweil, BA	6177855467	stefan.vanderweil@umassmed.edu

Locations

United States, Massachusetts
University of Massachusetts Medical School Clinical Research Center	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Celia Hartigan, RN, MPH 508-856-3676 Celia.Hartigan@umassmed.edu
Principal Investigator: John E. Harris, MD, PhD

Sponsors and Collaborators

University of Massachusetts, Worcester

Investigators

Principal Investigator:

John E. Harris, MD, PhD

University of Massachusetts, Worcester

More Information

No publications provided

Responsible Party:	John Harris, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:	NCT01517893 History of Changes
Other Study ID Numbers:	UM-DERM001
Study First Received:	January 13, 2012
Last Updated:	April 30, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Massachusetts, Worcester:

vitiligo
simvastatin

Additional relevant MeSH terms:

Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013