Topical Methotrexate for Psoriasis

  Methotrexate has been used as an effective systemic chemotherapeutic drug for psoriasis by dermatologists for over 30 years. Nevertheless, pharmacokinetic data indicate that oral methotrexate can cause a decrease in red and white blood cell and platelet counts and can also cause severe liver damage, diarrhea, and stomach irritation, as dose-related drug-induced side effects. Such indications have limited [prescription for oral methotrexate] by physicians. However, [Syed and Nordstrom of the Department of Dermatology, University of California-San Francisco, and researchers from three other locations note that] if its incorporation in a gel as a topical agent, in a proper dosage imparts better results without the cited side effects, then such a formulation appears to justify a clinical evaluation. Furthermore, published data have indicated that 70% of patients prefer topical therapy for treating psoriasis.

   Therefore, Syed et al. conducted a placebo-controlled double-blind study to evaluate the clinical efficacy and tolerability of methotrexate 0.25% in a hydroxyethylcellulose 1% applied topically to treat patients afflicted with psoriasis vulgaris. Sixty adult patients with slight to moderate chronic plaque-type psoriasis with a mean duration of disease of 9.6 years entered the study. Each patient was allocated a precoded tube (active or placebo) with instructions on how to self-administer the trial medication topically (without occlusion) to their lesions two times daily for 5 consecutive days per week with 4 weeks of active treatment. Patients were examined on a weekly basis and those showing total clearing or remission of lesions were considered effectively treated. At the end of the treatment, the code was broken and disclosed that methotrexate 0.25% gel had significantly treated more patients than placebo (83.3% vs. 6.7%), and cleared more plaques (82.2% vs. 4.3%). Laboratory evaluations, including CBC with differential and platelet count, renal function, liver chemistry (SGOT and SGPT), and serum creatinine, were within the normal limits. The treatment was well-tolerated by all the patients, with no adverse drug-related symptoms and no dropouts. The study was followed up for 12 months from the first day of the treatment; two cured patients had relapsed after 8 months. The conclusion: topical methotrexate 0.25% in a hydrophilic gel is well tolerated and significantly more effective than placebo to treat psoriasis vulgaris.         

J Cutan Med Surg 2001; 299-302
 Fourteen adult patients diagnosed clinically with plaque-type palmoplantar psoriasis (>30% of the palm and/or sole areas involved) applied topical methotrexate 0.25% in a hydroxygel base twice daily to the lesions for twelve weeks. None of the patients had complete clearance of lesions. The study concluded that a higher concentration in a different base with better penetration could possibly provide better results for patients with palmoplantar psoriasis. Tiwari, Kumar, et al published a case report of topical methotrexate solution delivered by iontophoresis once a week for four weeks. The researchers reported 75% improvement after four weeks of therapy. In general, iontophoresis allows high concentrations of drug to be delivered to a limited area, and may offer a method of reducing total drug accumulation and reduced side effects.

J Dermatol 2004 Oct;31(10):798-801? Int J Dermatol 2003 Feb;42(2):157-9

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