drugset / Trial / NCT06087796
Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata.
RandomizedParallel-groupOpen-labelTreatment
Summary
To compare the efficacy and safety of topical pentoxifylline 2% gel and topical metformin 10% gel versus topical betamethasone valerate 0.1% cream, in treatment of patchy alopecia areata.
Timeline
- Start
- 2023-10
- Primary completion
- 2024-09
- Completion
- 2024-10
Publications
- Background Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.
- Background Islam N, Leung PS, Huntley AC, Gershwin ME. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015 Feb;14(2):81-9. doi: 10.1016/j.autrev.2014.10.014. Epub 2014 Oct 12.
- Background Juarez-Rendon KJ, Rivera Sanchez G, Reyes-Lopez MA, Garcia-Ortiz JE, Bocanegra-Garcia V, Guardiola-Avila I, Altamirano-Garcia ML. Alopecia Areata. Current situation and perspectives. Arch Argent Pediatr. 2017 Dec 1;115(6):e404-e411. doi: 10.5546/aap.2017.eng.e404. English, Spanish.
- Background Karimkhani C, Boyers LN, Prescott L, Welch V, Delamere FM, Nasser M, Zaveri A, Hay RJ, Vos T, Murray CJ, Margolis DJ, Hilton J, MacLehose H, Williams HC, Dellavalle RP. Global burden of skin disease as reflected in Cochrane Database of Systematic Reviews. JAMA Dermatol. 2014 Sep;150(9):945-51. doi: 10.1001/jamadermatol.2014.709.
- Background Zargari O. Pentoxifylline: a drug with wide spectrum applications in dermatology. Dermatol Online J. 2008 Nov 15;14(11):2.
- Background Speirs C, Williams JJL, Riches K, Salt IP, Palmer TM. Linking energy sensing to suppression of JAK-STAT signalling: A potential route for repurposing AMPK activators? Pharmacol Res. 2018 Feb;128:88-100. doi: 10.1016/j.phrs.2017.10.001. Epub 2017 Oct 13.
- Background Speiser JJ, Mondo D, Mehta V, Marcial SA, Kini A, Hutchens KA. Regulatory T-cells in alopecia areata. J Cutan Pathol. 2019 Sep;46(9):653-658. doi: 10.1111/cup.13479. Epub 2019 May 15.
- Background Araoye EF, Thomas JAL, Aguh CU. Hair regrowth in 2 patients with recalcitrant central centrifugal cicatricial alopecia after use of topical metformin. JAAD Case Rep. 2020 Jan 22;6(2):106-108. doi: 10.1016/j.jdcr.2019.12.008. eCollection 2020 Feb. No abstract available.
- Background Tawfeek HM, Abou-Taleb DAE, Badary DM, Ibrahim M, Abdellatif AAH. Pharmaceutical, clinical, and immunohistochemical studies of metformin hydrochloride topical hydrogel for wound healing application. Arch Dermatol Res. 2020 Mar;312(2):113-121. doi: 10.1007/s00403-019-01982-1. Epub 2019 Oct 16.
- Background Jha AK, Udayan UK, Roy PK, Amar AKJ, Chaudhary RKP. Dermoscopy of alopecia areata-a retrospective analysis. Dermatol Pract Concept. 2017 Apr 30;7(2):53-57. doi: 10.5826/dpc.0702a12. eCollection 2017 Apr.
- Results El-Taweel AI, Akl EM. Intralesional pentoxifylline injection in localized alopecia areata. J Cosmet Dermatol. 2019 Apr;18(2):602-607. doi: 10.1111/jocd.12796. Epub 2018 Oct 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 10 % | Topical |
| Subject | Pentoxifylline | Small molecule | 2 % | Topical |
| Comparator | betamethasone valerate | Small molecule | 0.1 % | Topical |