Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Psoriasis

Summary

A pilot study on the formulation of topical methotrexate was conducted. Patients after baseline evaluation were randomly placed into either topical 1% methotrexate gel or clobetasol propionate 0.05% ointment which was applied for 6 weeks. PASI score was assessed at two-week intervals for a total of eight weeks. Blood chemistry parameters, whole abdomen ultrasound, and adverse drug reactions while on treatment and after eight weeks were monitored as secondary outcome measures.

Timeline

Start

2022-01-01

Primary completion

2023-12-31

Completion

2023-12-31

Publications

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• Background Hsu S, Papp KA, Lebwohl MG, Bagel J, Blauvelt A, Duffin KC, Crowley J, Eichenfield LF, Feldman SR, Fiorentino DF, Gelfand JM, Gottlieb AB, Jacobsen C, Kalb RE, Kavanaugh A, Korman NJ, Krueger GG, Michelon MA, Morison W, Ritchlin CT, Stein Gold L, Stone SP, Strober BE, Van Voorhees AS, Weiss SC, Wanat K, Bebo BF Jr; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. doi: 10.1001/archdermatol.2011.1410.
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• Background Pinto MF, Moura CC, Nunes C, Segundo MA, Costa Lima SA, Reis S. A new topical formulation for psoriasis: development of methotrexate-loaded nanostructured lipid carriers. Int J Pharm. 2014 Dec 30;477(1-2):519-26. doi: 10.1016/j.ijpharm.2014.10.067. Epub 2014 Nov 1.
• Background Dawson, B., & Trapp, R. G. (2001). Basic et clinical biostatistics. Buch. Lange Med. Books/Mcgraw-Hill.
• Background Coondoo A, Phiske M, Verma S, Lahiri K. Side-effects of topical steroids: A long overdue revisit. Indian Dermatol Online J. 2014 Oct;5(4):416-25. doi: 10.4103/2229-5178.142483.
• Background Zhou Y, Yang L, Lyu Y, Wu D, Zhu Y, Li J, Jiang D, Xin X, Yin L. Topical Delivery of ROS-Responsive Methotrexate Prodrug Nanoassemblies by a Dissolvable Microneedle Patch for Psoriasis Therapy. Int J Nanomedicine. 2023 Feb 18;18:899-915. doi: 10.2147/IJN.S394957. eCollection 2023.

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