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Clinical Trial of Simvastatin to Treat Generalized Vitiligo

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Harris, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01517893
First received: January 13, 2012
Last updated: October 22, 2014
Last verified: October 2014

January 13, 2012
October 22, 2014
January 2012
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01517893 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
 
Clinical Trial of Simvastatin to Treat Generalized Vitiligo
A Phase-II, Randomized, Placebo-controlled Trial of Simvastatin in Generalized Vitiligo

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vitiligo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2014
December 2013   (final data collection date for primary outcome measure)

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.
Male
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517893
UM-DERM001
Yes
John Harris, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: John E. Harris, MD, PhD University of Massachusetts, Worcester
University of Massachusetts, Worcester
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP