Clinical Trial of Simvastatin to Treat Generalized Vitiligo
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 11/16/2018 |
| Start Date: | January 2012 |
| End Date: | December 2014 |
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.
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.
Vitiligo is an autoimmune disease caused by autoreactive CD8+ T lymphocytes that target
melanocytes, and interferon-γ-induced CXCL10 plays an important role.1 Simvastatin inhibits
interferon-γ signaling by blocking activation of STAT12 and prevented and reversed disease in
our mouse model.3 A case report described a patient with vitiligo who repigmented with
simvastatin.4 We conducted a small, randomized, double-blind, placebo-controlled, phase II
clinical trial to test simvastatin as a treatment for vitiligo. After obtaining informed
consent, we enrolled men ages 18 to 64 years with vitiligo affecting 3% to 50% of their body
surface area (BSA). We excluded patients with a segmental presentation; those already taking
3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor; those with existing thyroid
disease; and women, based on their increased risk of simvastatin-induced myopathy.
melanocytes, and interferon-γ-induced CXCL10 plays an important role.1 Simvastatin inhibits
interferon-γ signaling by blocking activation of STAT12 and prevented and reversed disease in
our mouse model.3 A case report described a patient with vitiligo who repigmented with
simvastatin.4 We conducted a small, randomized, double-blind, placebo-controlled, phase II
clinical trial to test simvastatin as a treatment for vitiligo. After obtaining informed
consent, we enrolled men ages 18 to 64 years with vitiligo affecting 3% to 50% of their body
surface area (BSA). We excluded patients with a segmental presentation; those already taking
3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor; those with existing thyroid
disease; and women, based on their increased risk of simvastatin-induced myopathy.
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.
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