Oral Metformin for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
VitiligoMetformin Hydrochloride - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Week 24

Week 24
Enzymes
F-VASI 50
Ions
Metformin

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Vildagliptin (LAF237)
13%Nasopharyngitis
10%Hyperhidrosis
9%Tremor
9%Hunger
8%Asthenia
6%Hypoglycaemia
1%Squamous cell carcinoma of the tongue
1%Femoral neck fracture
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02002221) in the Vildagliptin (LAF237) ARM group. Side effects include: Nasopharyngitis with 13%, Hyperhidrosis with 10%, Tremor with 9%, Hunger with 9%, Asthenia with 8%.

Trial Design

1 Treatment Group

Oral Metformin
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Oral Metformin · No Placebo Group · Phase 2

Oral Metformin
Drug
Experimental Group · 1 Intervention: Metformin Hydrochloride · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~440

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 24

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
309 Previous Clinical Trials
742,024 Total Patients Enrolled
John E Harris, MD, PhDPrincipal InvestigatorChair, Department of Dermatology

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a non-English speaking adult aged 18 years or older.

Who else is applying?

What state do they live in?
New Jersey50.0%
Oregon50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
UMass Chan Medical School100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How many prior treatments have patients received?
0100.0%
References