drugset / Trial / NCT05300009
Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts
RandomizedParallel-groupOpen-labelOther
Summary
To study the clinical efficacy of the topically applied MTX hydrogel preparation combined with microneedling to increase drug delivery and efficacy in comparison with cryotherapy in treatment of warts.
Timeline
- Start
- 2022-06-15
- Primary completion
- 2023-06-15
- Completion
- 2023-08-15
Publications
- Background Ghittoni R, Accardi R, Chiocca S, Tommasino M. Role of human papillomaviruses in carcinogenesis. Ecancermedicalscience. 2015 Apr 29;9:526. doi: 10.3332/ecancer.2015.526. eCollection 2015.
- Background Kimura U, Takeuchi K, Kinoshita A, Takamori K, Suga Y. Long-pulsed 1064-nm neodymium:yttrium-aluminum-garnet laser treatment for refractory warts on hands and feet. J Dermatol. 2014 Mar;41(3):252-7. doi: 10.1111/1346-8138.12411. Epub 2014 Feb 10.
- Background Shaheen MA, Salem SA, Fouad DA, El-Fatah AA. Intralesional tuberculin (PPD) versus measles, mumps, rubella (MMR) vaccine in treatment of multiple warts: a comparative clinical and immunological study. Dermatol Ther. 2015 Jul-Aug;28(4):194-200. doi: 10.1111/dth.12230. Epub 2015 Apr 6.
- Background Sung JY, Hong JH, Kang HS, Choi I, Lim SD, Lee JK, Seok JH, Lee JH, Hur GM. Methotrexate suppresses the interleukin-6 induced generation of reactive oxygen species in the synoviocytes of rheumatoid arthritis. Immunopharmacology. 2000 Apr;47(1):35-44. doi: 10.1016/s0162-3109(99)00185-x.
- Background Cipriani P, Ruscitti P, Carubbi F, Liakouli V, Giacomelli R. Methotrexate: an old new drug in autoimmune disease. Expert Rev Clin Immunol. 2014 Nov;10(11):1519-30. doi: 10.1586/1744666X.2014.962996. Epub 2014 Sep 22.
- Background Beck S, Zhu Z, Oliveira MF, Smith DM, Rich JN, Bernatchez JA, Siqueira-Neto JL. Mechanism of Action of Methotrexate Against Zika Virus. Viruses. 2019 Apr 10;11(4):338. doi: 10.3390/v11040338.
- Background Duarte AA, Carneiro GP, Murari CM, Jesus LCB. Nail psoriasis treated with intralesional methotrexate infiltration. An Bras Dermatol. 2019 Oct 17;94(4):491-492. doi: 10.1590/abd1806-4841.20198170. eCollection 2019. No abstract available.
- Background Sutton L, Swinehart JM, Cato A, Kaplan AS. A clinical study to determine the efficacy and safety of 1% methotrexate/Azone (MAZ) gel applied topically once daily in patients with psoriasis vulgaris. Int J Dermatol. 2001 Jul;40(7):464-7. doi: 10.1046/j.1365-4362.2001.01244.x. No abstract available.
- Background Abdo HM, Elrewiny EM, Elkholy MS, Ibrahim SM. Efficacy of intralesional methotrexate in the treatment of plantar warts. Dermatol Ther. 2020 Mar;33(2):e13228. doi: 10.1111/dth.13228. Epub 2020 Jan 29.
- Background Dehshahri A, Kumar A, Madamsetty VS, Uzieliene I, Tavakol S, Azedi F, Fekri HS, Zarrabi A, Mohammadinejad R, Thakur VK. New Horizons in Hydrogels for Methotrexate Delivery. Gels. 2020 Dec 30;7(1):2. doi: 10.3390/gels7010002.
- Background Badran MM, Kuntsche J, Fahr A. Skin penetration enhancement by a microneedle device (Dermaroller) in vitro: dependency on needle size and applied formulation. Eur J Pharm Sci. 2009 Mar 2;36(4-5):511-23. doi: 10.1016/j.ejps.2008.12.008. Epub 2008 Dec 25.
- Background Ita K. Dissolving microneedles for transdermal drug delivery: Advances and challenges. Biomed Pharmacother. 2017 Sep;93:1116-1127. doi: 10.1016/j.biopha.2017.07.019. Epub 2017 Jul 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 1 % | Topical |