Phase 2
N=15
Clinical Trial of Simvastatin to Treat Generalized Vitiligo
Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT01517893 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Mar 2015
Primary outcome: Primary: Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Simvastatin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- John Harris
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score |
0; 0 | — |
| SECONDARY Number of Participants With Increase in Investigator's Global Assessment Score |
1; 0 | — |
| SECONDARY Number of Participants Experiencing Toxicity From of High-dose Simvastatin . |
0; 0 | — |
| SECONDARY Change in Sentinel Patch Area |
-0.2272; 3.8571 | — |
| SECONDARY Change in Quality of Life Score by Using DERMATOLOGY LIFE QUALITY INDEX (DLQI) |
3.4; 2.285714286 | — |
| SECONDARY Number of Participants With an Increase in Patient's Global Assessment Score |
0; 1 | — |
| SECONDARY Serum CXCL10 Levels From the First and Last Available Clinic Visits Were Measured Via ELISA |
0.9148; 0.6176 | — |
| SECONDARY CXCR3 Expression on CD8+ T Cells |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01517893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.