Clinical Trial of Simvastatin to Treat Generalized Vitiligo

• 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

• 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
• STAT1 activation and CXCR3 expression in CD8+ T cells [ Time Frame: Assessed at screening visit and every visit thereafter for the duration of the trial (monthly for up to 8 months) ] [ Designated as safety issue: No ]
  Determination of the effects of simvastatin treatment on STAT1 activation status and 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

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.

• 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

• Experimental: Intervention arm
  Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated
  Intervention: Drug: Simvastatin
• Placebo Comparator: Placebo Arm
  Intervention: Drug: Placebo

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.