Clinical trial
Metformin as a Novel Treatment for Vitiligo by Targeting CD8+ T Cell Metabolism
Name
STUDY00000630
Description
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.
Trial arms
Trial start
2023-05-01
Estimated PCD
2027-07-01
Trial end
2027-11-01
Status
Recruiting
Phase
Early phase I
Treatment
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 at bedtime for the remainder of the study.
Arms:
Oral Metformin
Other names:
Glucophage, Glumetza, Riomet
Size
30
Primary endpoint
F-VASI 50
Week 24
Eligibility criteria
Inclusion Criteria:
* Adults 18 years and older with stable vitiligo
* Stable vitiligo is defined as no new spots of depigmentation or expansion of any existing spots for one year;
* Willingness to participate in the study;
* Willingness to undergo suction blistering;
* Non-English speaking adults may be enrolled with the assistance of an interpreter and the use of an IRB-approved short form in the subject's language;
* Informed consent document signed by the subject;
Exclusion Criteria:
* Adults unable to consent (adults lacking capacity);
* Active vitiligo defined by presence of confetti lesions, trichrome lesions, and Koebner's phenomenon;
* Individuals who are not yet adults (infants, children, teenagers);
* Pregnant women and/or breastfeeding, or those who have recently delivered a baby within the past 6 months;
* Prisoners;
* Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks;
* Topical steroids within the prior 2 weeks;
* Currently undergoing UVB light therapy or history of light therapy within the past 8 weeks;
* Unable to return for follow-up visits;
* Enrolled in a clinical study of any other investigational drug or device;
* Diabetes, liver disease, or kidney disease;
* Hypoglycemia as defined by fasting blood glucose \<70 mg/dL assessed at a fasting study visit;
* Prescription medication or cosmetics containing: retinoids, glycolic acid, salicylic acid, or any other remedies that might affect the healing process. Non-medicated moisturizers are allowed. If the person is unsure, they can bring in any products for our review;
* Self-reported history of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator;
* Any other condition or laboratory value that would, in the professional opinion of the investigators, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label (unmasked) study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label (unmasked)'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-06-02
1 organization
1 drug
1 indication
Organization
University of Massachusetts, WorcesterDrug
MetforminIndication
Vitiligo