Evaluating the Efficacy and Safety of Metformin in Vitiligo

Trial details

Who runs it

University of Massachusetts, Worcester

Trial code

NCT05607316

Record updated

24 September 2024

Original description

Metformin modulates metabolism in multiple cell types and is currently used to reduce glucose levels and insulin resistance in diabetic patients. The investigators hypothesize that oral metformin can regulate the metabolism of CD8+ T cells, reduce their cytotoxic activity and thus serve as a novel treatment for vitiligo.Read full original descriptionShow less

Metformin as a Novel Treatment for Vitiligo by Targeting CD8+ T Cell Metabolism

Metformin modulates metabolism in multiple cell types and is currently used to reduce glucose levels and insulin resistance in diabetic patients. The investigators hypothesize that oral metformin can regulate the metabolism of CD8+ T cells, reduce their cytotoxic activity and thus serve as a novel treatment for vitiligo.

Inclusion: Adults 18 years - 100 years of age with stable vitiligo; Stable vitiligo is defined as no new spots of depigmentation or expansion of any existing spots for one year; Total body surface area BSA >/= 1%; Facial body surface area BSA >/= 0.25%; Willingness to participate in the study; Willingness to undergo suction blistering; Non-English speaking adults may be enrolled with the assistance of an interpreter and the use of an IRB-approved short form in the subject's language; Informed consent document signed by the subject.

Exclusion: Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks; Topical steroids within the prior 2 weeks; Enrolled in a clinical study of any other investigational drug or device; Prescription medication or cosmetics containing: retinoids, glycolic acid, salicylic acid, or any other remedies that might affect the healing process. Non-medicated moisturizers are allowed. If the person is unsure, they can bring in any products for our review; Self-reported history of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator; Currently undergoing UVB light therapy or history of light therapy within the past 8 weeks; Diabetes, liver disease, or kidney disease; Hypoglycemia as defined by fasting blood glucose <70 mg/dL assessed at a fasting study visit; Any other condition or laboratory value that would, in the professional opinion of the investigators, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject; Adults unable to consent (adults lacking capacity); Active vitiligo defined by presence of confetti lesions, trichrome lesions, and Koebner's phenomenon; Individuals who are not yet adults (infants, children, teenagers); Pregnant women and/or breastfeeding, or those who have recently delivered a baby within the past 6 months; Prisoners; Unable to return for follow-up visits.

ClinicalTrials.gov NCT05607316