What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for vitiligo include topical corticosteroids, calcineurin inhibitors, and phototherapy. Topical corticosteroids can cause skin thinning, stretch marks, and acne. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, may cause burning or itching at the application site and have a potential risk for lymphoma and skin cancer with long-term use. Phototherapy can lead to sunburn, increased risk of skin cancer, and premature skin aging. Metformin, being studied for its immunomodulatory effects, is generally well-tolerated but can cause gastrointestinal issues like nausea, diarrhea, and abdominal discomfort.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved treatments for vitiligo that modulate the metabolism of CD8+ T cells to reduce cytotoxic activity, similar to metformin. However, treatments for vitiligo often focus on immune modulation, including the use of immunosuppressants and biologics that target various aspects of the immune response. For instance, JAK inhibitors and other immunosuppressive therapies are being explored for their potential to manage autoimmune conditions like vitiligo by modulating T cell activity.

What other types of research exist?

Promising, novel alternatives to Metformin for Vitiligo patients could include therapies targeting specific immune pathways, such as IL-23/T17 inhibitors, or biologics like ustekinumab, which are used in treating other autoimmune skin conditions like psoriasis. Advancements in immunotherapy and targeted biologics for autoimmune diseases may also offer potential treatment options.

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Biguanide

Metformin for Vitiligo

Phase 2

Waitlist Available

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

Must not have

Unable to return for follow-up visits

Active vitiligo defined by presence of confetti lesions, trichrome lesions, and Koebner's phenomenon

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests metformin, a diabetes drug, on people with stable vitiligo. The drug may help restore color to the skin by reducing the activity of specific immune cells.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot come back for follow-up visits.

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I have active vitiligo with specific skin changes.

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I am under 18 years old.

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I haven't used any topical steroids in the last 2 weeks.

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I haven't taken any immune-weakening medication in the last 4 weeks.

Select...

I am unable to make medical decisions for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Define the different populations of cells by flow cytometry

Secondary study objectives

Define the inflammatory conditions in the lesions

Face-Vitiligo Area Scoring Index 50% improvement (F-VASI50) after 6 months of treatment

Measure the abundance of metabolites with untargeted metabolomics in the blister fluid and cells from non-lesional and lesional areas, and in plasma

+1 more

Side effects data

From 2023 Phase 2 trial • 40 Patients • NCT03733132

35%

Diarrhea

10%

Anemia

10%

Nausea

10%

Gastroesophageal reflux disease

Hepatobiliary disorders

Fall

Weight loss

COVID-19 Infection

Flatulence

Pain

Social circumstances

Vomiting

Headache

Stroke

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Metformin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1990

0 / 6Eligibility criteria met

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.