A clinical study to determine the efficacy and safety of 1% methotrexate/Azone^® (MAZ) gel applied topically once daily in patients with psoriasis vulgaris

Abstract

The efficacy and safety of an Azone‐enhanced topical gel formulation of 1% methotrexate (MAZ), administered once daily for 8 weeks, was compared with that of placebo vehicle for the treatment of severe plaque psoriasis. Fifty‐three patients were involved in this double‐blind, paired‐comparison study. Changes in disease signs and symptoms indicated that both agents have antipsoriatic activity; however, lesions treated with MAZ exhibited significantly greater improvement. At the end of treatment, 27% of MAZ‐treated lesions demonstrated marked improvement, whereas none of the placebo‐treated lesions exhibited this degree of change. MAZ was most effective in reducing lesional scaling and thickness (P < 0.05 vs. placebo). Thirty‐seven patients experienced adverse events. The majority were local in nature and mild to moderate in degree. No clinically significant changes in hematologic or clinical laboratory parameters were observed, and concentrations of methotrexate were demonstrable in only two of 296 plasma samples. The findings suggest that the MAZ formulation provides percutaneous absorption of methotrexate in amounts sufficient for a beneficial effect in psoriasis, but insufficient to exert systemic toxicities.

Development, evaluation and clinical studies of Acitretin loaded nanostructured lipid carriers for topical treatment of psoriasis

“…Progress was evaluated on a weekly basis by a group of physicians in terms of improvement in Psoriasis Area and Severity Index (PASI) score, Overall Lesion Severity Scale (OLS), Physician's Assessment (PA), Psoriasis Symptom Assessment (PSA) and Safety and Tolerability Assessment (STA) (Lynda Sutton, 2001). The PASI score was calculated as the sum of the severity of the main symptoms multiplied by the numerical value of the area involved with various percentages of the 3 main body areas.…”

Optimization of Iontophoretic Parameters for the Transdermal Delivery of Methotrexate

“…Previously various formulation strategies and enhancement techniques have been used to enhance the transdermal delivery of MTX (Vaidyanathan, Chaubal, and Vassarada 1985;Alvarez-Figueroa, Delgado-Charro, and Blanco-Mendez 2001;Sutton et al 2001;Wong et al 2005;Vemulapalli et al 2008). Tiwari et al (2003) studied the clinical efficacy of MTX by means of iontophoresis and suggested that a short application of current is sufficient for the treatment of psoriasis.…”

Topical delivery of methotrexate via skin pretreated with physical enhancement techniques: low‐fluence erbium:YAG laser and electroporation

“…Being water-soluble and negatively charged, MTX is not readily transported into the skin by passive diffusion. The clinical response is also limited when MTX is topically applied [16]. In the present study, we used two physical techniques, a lowfluence Er:YAG laser and electroporation, to enhance the skin permeation of MTX.…”