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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
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 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
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
~1460
Find a Location
Who is running the clinical trial?
University of Massachusetts, WorcesterLead Sponsor
343 Previous Clinical Trials
986,580 Total Patients Enrolled
John E Harris, MD, PhDPrincipal InvestigatorChair, Department of Dermatology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult with stable vitiligo.Any other health issue or test result that, according to the experts, might affect how you respond to the treatment or the accuracy of the study results, or might be risky for you.My vitiligo has not changed for one year.You are a non-English speaking adult aged 18 years or older.I am willing to participate in the study.My vitiligo has not changed for one year.I am willing to undergo a procedure that creates small blisters on my skin for testing.I am willing to undergo a procedure that creates small blisters on my skin for testing.I use products that may affect healing, but I can bring them for review.I cannot come back for follow-up visits.I have active vitiligo with specific skin changes.I am under 18 years old.I haven't used any topical steroids in the last 2 weeks.I am currently receiving UVB light therapy or had it within the last 8 weeks.I am willing to participate in the study.I haven't taken any immune-weakening medication in the last 4 weeks.I have diabetes, liver, or kidney disease.I am unable to make medical decisions for myself.Your blood sugar is too low when you haven't eaten for a while.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Metformin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree may Oral Metformin be detrimental to a patient's well-being?
"Based on our evaluation, the Safety Rating of Oral Metformin is 2 due to it being in Phase 2. This implies that there is existing evidence for its safety but none as yet verifying its efficacy."
Answered by AI
Are there any vacancies for individuals to participate in this research?
"Evidenced on clinicaltrials.gov, this research trial is no longer enrolling patients; the listing was first posted November 1st 2022 and last edited November 6th 2022. Although it has concluded recruitment, 37 other trials are actively seeking participants at present."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
New Jersey
How old are they?
18 - 65
What site did they apply to?
UMass Chan Medical School
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
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