A phase-II, randomized, placebo-controlled trial of simvastatin in generalized vitiligo
Principle Investigator: John E. Harris, MD, PhD
Study Location: UMass Memorial Medical Center in Worcester, MA
A research trial at UMass is studying whether simvastatin, a common cholesterol medication, is useful in treating vitiligo. The study includes taking either this medication or a placebo and visiting UMass 8 times over a period of 6-7 months. You will be compensated for your time and receive free parking.
You may be eligible if you are a patient with vitiligo and areEligibility
| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- male gender
- ages 18-64
- at least one vitiligo skin lesion measuring at least 2×2 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517893
Contacts
| Contact: John E. Harris, MD, PhD | 508-856-1982 | John.Harris@umassmed.edu |
| Contact: Stefan Vanderweil, BA | 6177855467 | stefan.vanderweil@umassmed.edu |
Locations
| United States, Massachusetts | |
| University of Massachusetts Medical School Clinical Research Center | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Celia Hartigan, RN, MPH 508-856-3676 Celia.Hartigan@umassmed.edu | |
| Principal Investigator: John E. Harris, MD, PhD | |
Courtesy of http://clinicaltrials.gov/ct2/show/NCT01517893
This limit poses problems for many vitiligo patients, as more than 12-24 months of treatment, or more than 200 treatments, are often required for repigmentation. A recent review of patient experience by doctors at University of California, San Francisco (UCSF), now suggests that this limit may be unnecessarily low.
