A Phase 2 interventional study of Metformin Hydrochloride in Vitiligo, sponsored by University of Massachusetts, Worcester. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by University of Massachusetts, Worcester · Phase 2, Interventional, and Treatment
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.
Metformin modulates metabolism in multiple cell types and is currently used to reduce glucose levels and insulin resistance in diabetic patients. It has been reported that the use of metformin correlated with a lower risk of developing vitiligo, suggesting that metformin could potentially mitigate the disease. The investigators found that treating mouse T cells with metformin during activation reduced their mitochondrial respiration and proliferation, while mice treated with metformin reversed their vitiligo. Therefore, the investigators hypothesize that regulation of CD8+ T cell metabolism in vitiligo patients by metformin will reduce their proliferation and cytotoxic activity, resulting in skin repigmentation and thus serve as a novel treatment.
The investigators plan to treat approximately 30 subjects with stable vitiligo.
Metformin is FDA-approved for use with dosing from 500-2000 mg/day. It has a rare risk of lactic acidosis, which can be meaningful in patients with risk factors such as renal insufficiency. This risk is directly proportional to the dose given; therefore, participants will be started at a lower dose (500 mg twice daily) with follow-up to monitor any arising symptoms. Per current clinical recommendations, participants will only be increased to higher-dose metformin (1000 mg twice daily) if the initial dose is tolerated.
298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.
Browse Vitiligo studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults 18 years - 100 years of age with stable vitiligo
Exclusion Criteria:
Treatment with metformin will be started at 500 mg twice daily and increased to 1000 mg twice daily only after they have tolerated the treatment.
Drug: Metformin Hydrochloride
Consistent with previous studies and clinical recommendations, subjects will initiate treatment at metformin 500 mg twice daily and increase to 1000 mg twice daily only after they have tolerated the treatment (details below). Study Visit 1 (Week 1) - Study Visit 2 (Week 2) Subjects will be directed to take metformin 500 mg twice daily. Study Visit 2 (Week 2) - Study Visit 5 (Week 24) If initial metformin dose is tolerated, subjects will be directed to increase the dose to 1000 mg by mouth twice daily for the remainder of the study.
Also known as: Glucophage, Glumetza, Riomet
Define the different populations of cells by flow cytometry
Determine any change in the subpopulations of CD8+ T cells using CD69 and CD103 for Trm and CD122 (IL15Rb chain) as a marker for long-lived Trm; CD44, CD62L, and CD127 for central and effector memory T cells; and CXCR3 to indicate trafficking of CD8+ T cells.
Time frame: Week 24
Define the inflammatory conditions in the lesions
Protein biomarker discovery using Olink® proteomics technology platform (inflammation panel)
Time frame: Week 24
Measure the abundance of metabolites with untargeted metabolomics in the blister fluid and cells from non-lesional and lesional areas, and in plasma
Liquid chromatography-mass spectrometry
Time frame: Week 24
Vitiligo Area Scoring Index 50% improvement (VASI50) after 6 months of treatment
Assess VASI at baseline and after 3 months of starting treatment.
Time frame: Week 24
Face-Vitiligo Area Scoring Index 50% improvement (F-VASI50) after 6 months of treatment
Assess facial VASI at baseline and after 6 months of starting treatment.
Time frame: Week 24
Plan to share: No
This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Worcester