Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01517893
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01517893
Study Brief:
Protocol Section:
NCT01517893