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
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Week 24
Week 24
Enzymes
F-VASI 50
Ions
Metformin
Trial Safety
Safety Progress
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
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: DrugTreatment
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 Jersey | 50.0% |
| Oregon | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| UMass Chan Medical School | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Tomczynska M, Bijak M, Saluk J. Metformin - The Drug for the Treatment of Autoimmune Diseases; A New Use of a Known Anti-Diabetic Drug. Curr Top Med Chem. 2016;16(19):2223-30. Review.
- Rashighi M, Agarwal P, Richmond JM, Harris TH, Dresser K, Su MW, Zhou Y, Deng A, Hunter CA, Luster AD, Harris JE. CXCL10 is critical for the progression and maintenance of depigmentation in a mouse model of vitiligo. Sci Transl Med. 2014 Feb 12;6(223):223ra23. doi: 10.1126/scitranslmed.3007811.
- Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.
- Salvatore T, Pafundi PC, Galiero R, Gjeloshi K, Masini F, Acierno C, Di Martino A, Albanese G, Alfano M, Rinaldi L, Sasso FC. Metformin: A Potential Therapeutic Tool for Rheumatologists. Pharmaceuticals (Basel). 2020 Sep 4;13(9). pii: E234. doi: 10.3390/ph13090234. Review.
- Ogg GS, Rod Dunbar P, Romero P, Chen JL, Cerundolo V. High frequency of skin-homing melanocyte-specific cytotoxic T lymphocytes in autoimmune vitiligo. J Exp Med. 1998 Sep 21;188(6):1203-8.
- Doyle-Delgado K, Chamberlain JJ, Shubrook JH, Skolnik N, Trujillo J. Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline. Ann Intern Med. 2020 Nov 17;173(10):813-821. doi: 10.7326/M20-2470. Epub 2020 Sep 1.
- Cui Y, Chang L, Wang C, Han X, Mu L, Hao Y, Liu C, Zhao J, Zhang T, Zhang H, Zhang Y, Liu Y, Zhao W, Wang J, Liu X, Sun B, Wang G, Kong Q, Han J, Li H. Metformin attenuates autoimmune disease of the neuromotor system in animal models of myasthenia gravis. Int Immunopharmacol. 2019 Oct;75:105822. doi: 10.1016/j.intimp.2019.105822. Epub 2019 Aug 19.
- Cornell S. Comparison of the diabetes guidelines from the ADA/EASD and the AACE/ACE. J Am Pharm Assoc (2003). 2017 Mar - Apr;57(2):261-265. doi: 10.1016/j.japh.2016.11.005. Epub 2017 Jan 5.
- DeFronzo R, Fleming GA, Chen K, Bicsak TA. Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism. 2016 Feb;65(2):20-9. doi: 10.1016/j.metabol.2015.10.014. Epub 2015 Oct 9. Review.
- Elbuluk N, Ezzedine K. Quality of Life, Burden of Disease, Co-morbidities, and Systemic Effects in Vitiligo Patients. Dermatol Clin. 2017 Apr;35(2):117-128. doi: 10.1016/j.det.2016.11.002. Review.
- Richmond JM, Bangari DS, Essien KI, Currimbhoy SD, Groom JR, Pandya AG, Youd ME, Luster AD, Harris JE. Keratinocyte-Derived Chemokines Orchestrate T-Cell Positioning in the Epidermis during Vitiligo and May Serve as Biomarkers of Disease. J Invest Dermatol. 2017 Feb;137(2):350-358. doi: 10.1016/j.jid.2016.09.016. Epub 2016 Sep 26.
- Frisoli ML, Essien K, Harris JE. Vitiligo: Mechanisms of Pathogenesis and Treatment. Annu Rev Immunol. 2020 Apr 26;38:621-648. doi: 10.1146/annurev-immunol-100919-023531. Epub 2020 Feb 4. Review.
- Zhang Y, Cai Y, Shi M, Jiang S, Cui S, Wu Y, Gao XH, Chen HD. The Prevalence of Vitiligo: A Meta-Analysis. PLoS One. 2016 Sep 27;11(9):e0163806. doi: 10.1371/journal.pone.0163806. eCollection 2016.
- Salzes C, Abadie S, Seneschal J, Whitton M, Meurant JM, Jouary T, Ballanger F, Boralevi F, Taieb A, Taieb C, Ezzedine K. The Vitiligo Impact Patient Scale (VIPs): Development and Validation of a Vitiligo Burden Assessment Tool. J Invest Dermatol. 2016 Jan;136(1):52-8. doi: 10.1038/JID.2015.398.
- Sanchez-Rangel E, Inzucchi SE. Metformin: clinical use in type 2 diabetes. Diabetologia. 2017 Sep;60(9):1586-1593. doi: 10.1007/s00125-017-4336-x. Epub 2017 Aug 2. Review.
- Agius L, Ford BE, Chachra SS. The Metformin Mechanism on Gluconeogenesis and AMPK Activation: The Metabolite Perspective. Int J Mol Sci. 2020 May 3;21(9). pii: E3240. doi: 10.3390/ijms21093240. Review.
- DeFronzo R, Fleming GA, Chen K, Bicsak TA. Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism. 2016 Feb;65(2):20-9. doi: 10.1016/j.metabol.2015.10.014. Epub 2015 Oct 9.
- Elbuluk N, Ezzedine K. Quality of Life, Burden of Disease, Co-morbidities, and Systemic Effects in Vitiligo Patients. Dermatol Clin. 2017 Apr;35(2):117-128. doi: 10.1016/j.det.2016.11.002.
- Ogg GS, Rod Dunbar P, Romero P, Chen JL, Cerundolo V. High frequency of skin-homing melanocyte-specific cytotoxic T lymphocytes in autoimmune vitiligo. J Exp Med. 1998 Sep 21;188(6):1203-8. doi: 10.1084/jem.188.6.1203.
- Frisoli ML, Essien K, Harris JE. Vitiligo: Mechanisms of Pathogenesis and Treatment. Annu Rev Immunol. 2020 Apr 26;38:621-648. doi: 10.1146/annurev-immunol-100919-023531. Epub 2020 Feb 4.
- Sanchez-Rangel E, Inzucchi SE. Metformin: clinical use in type 2 diabetes. Diabetologia. 2017 Sep;60(9):1586-1593. doi: 10.1007/s00125-017-4336-x. Epub 2017 Aug 2.
- Agius L, Ford BE, Chachra SS. The Metformin Mechanism on Gluconeogenesis and AMPK Activation: The Metabolite Perspective. Int J Mol Sci. 2020 May 3;21(9):3240. doi: 10.3390/ijms21093240.
- Tomczynska M, Bijak M, Saluk J. Metformin - The Drug for the Treatment of Autoimmune Diseases; A New Use of a Known Anti-Diabetic Drug. Curr Top Med Chem. 2016;16(19):2223-30. doi: 10.2174/1568026616666160216152324.
- Salvatore T, Pafundi PC, Galiero R, Gjeloshi K, Masini F, Acierno C, Di Martino A, Albanese G, Alfano M, Rinaldi L, Sasso FC. Metformin: A Potential Therapeutic Tool for Rheumatologists. Pharmaceuticals (Basel). 2020 Sep 4;13(9):234. doi: 10.3390/ph13090234.
- Cornell S. Comparison of the diabetes guidelines from the ADA/EASD and the AACE/ACE. J Am Pharm Assoc (2003). 2017 Mar-Apr;57(2):261-265. doi: 10.1016/j.japh.2016.11.005. Epub 2017 Jan 5.
- John Harris 2022. "Evaluating the Efficacy and Safety of Metformin in Vitiligo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05607316.
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