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Biguanide

Metformin for Vitiligo

Phase 2
Recruiting
Led By John E Harris, MD, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Study Summary

This trial will test if metformin can reduce the activity of CD8+ T cells in vitiligo patients to treat the disease.

Who is the study for?
This trial is for adults over 18 with stable vitiligo, which means no new or expanding spots for a year. Participants must be willing to undergo suction blistering and have not used certain skin treatments recently. It's not for pregnant women, those on systemic immunosuppressants, UVB therapy patients, or individuals with diabetes, liver/kidney disease.Check my eligibility
What is being tested?
The trial tests if Metformin Hydrochloride can treat vitiligo by changing the metabolism of specific immune cells (CD8+ T cells) to reduce their harmful activity. The study involves taking oral metformin and monitoring its effects on the skin condition.See study design
What are the potential side effects?
While the side effects are not explicitly listed here, common side effects of Metformin include digestive issues like nausea and diarrhea, potential vitamin B12 deficiency with long-term use, and in rare cases a serious condition called lactic acidosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
F-VASI 50
Secondary outcome measures
Enzymes
Ions
Metformin

Side effects data

From 2023 Phase 2 trial • 40 Patients • NCT03733132
35%
Diarrhea
10%
Gastroesophageal reflux disease
10%
Nausea
10%
Anemia
5%
Pain
5%
Social circumstances
5%
Vomiting
5%
Headache
5%
Stroke
5%
Flatulence
5%
Hepatobiliary disorders
5%
COVID-19 Infection
5%
Hypertension
5%
Fall
5%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral MetforminExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~1440

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Vitiligo, such as Metformin, corticosteroids, and calcineurin inhibitors, primarily work by modulating the immune system. Metformin is thought to reduce the cytotoxic activity of CD8+ T cells, which are involved in the destruction of melanocytes. Corticosteroids suppress the overall immune response, while calcineurin inhibitors specifically inhibit T-cell activation. These mechanisms are important for Vitiligo patients because they target the underlying autoimmune process, potentially allowing for repigmentation and better disease management.

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
350 Previous Clinical Trials
989,800 Total Patients Enrolled
John E Harris, MD, PhDPrincipal InvestigatorChair, Department of Dermatology

Media Library

Metformin Hydrochloride (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05607316 — Phase 2
Vitiligo Research Study Groups: Oral Metformin
Vitiligo Clinical Trial 2023: Metformin Hydrochloride Highlights & Side Effects. Trial Name: NCT05607316 — Phase 2
Metformin Hydrochloride (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607316 — Phase 2
~20 spots leftby Jul 2027