Clinical Trial of Simvastatin to Treat Generalized Vitiligo (NCT01517893) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial of Simvastatin to Treat Generalized Vitiligo
United States15 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score
Timeframe: Assessed at baseline and final study visit, 6 months after randomization