Clinical Trial of Simvastatin to Treat Generalized Vitiligo

NCT01517893 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UM-DERM001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitiligo

Keywords

vitiligo; simvastatin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score

  Number of participants with 33% decrease in the Vitiligo Area Scoring Index (VASI) from baseline to the last available study visit. Decrease in VASI score means improvement. Minimum value is 0, that means no vitiligo. maximum value is 100, that means 100% of the body surface area has vitiligo (total body surface area).

  Assessed at baseline and final study visit, 6 months after randomization

Secondary Outcomes (7)

• Number of Participants With Increase in Investigator's Global Assessment Score

  Assessed at baseline and final study visit, 6 months after randomization

• Number of Participants Experiencing Toxicity From of High-dose Simvastatin .

  Assessed at baseline, then monthly until final study visit, six months after randomization.

• Change in Sentinel Patch Area

  Assessed at baseline and final study visit, 6 months after randomization

• Change in Quality of Life Score by Using DERMATOLOGY LIFE QUALITY INDEX (DLQI)

  Assessed at baseline and final study visit, 6 months after randomization

• Number of Participants With an Increase in Patient's Global Assessment Score

  Assessed at baseline and final study visit, 6 months after randomization

Study Arms (2)

Intervention arm

EXPERIMENTAL

Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated

Drug: Simvastatin

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Simvastatin DRUG

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

Intervention arm

Placebo DRUG

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Harris: lead

Study Sites (1)

University of Massachusetts Medical School Clinical Research Center

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

The following outcome measures were abandoned: 1.Decrease in CXCR3 exp. on CD8 positive T-Cells, 2.Corr. Among Var. Outcome Measures for Vitiligo: procedures not performed/no data collected due to strength of prior outcomes \& budget limitation.

Results Point of Contact

• Title: John E. Harris, MD, PhD
• Organization: University of Massachusetts Medical School

john.harris@umassmed.edu

508-856-1982

Study Officials

• John E. Harris, MD, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 14, 2018
• Results First Posted: March 12, 2015

Record last verified: 2018-10

Locations

US (1)