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A Randomized Controlled Trial Comparing Methotrexate Iontophoresis and Oral Methotrexate for the Treatment of
Suvigya Sachan1, Mitanjali Sethy2, Shibashis Chatterjee3
1Department of Dermatology, Venereology, and Leprosy, All India Institute of Medical Sciences, Mangalagiri, IND.
Background:
Palmoplantar hyperkeratotic eczema is quite disabling and affects a person's daily quality of life. Among the various treatment options available, oral methotrexate was quite effective. However, it was associated with systemic and cutaneous side effects. Therefore, delivery of methotrexate through Iontophoresis was an option to reduce the adverse effects and to enhance the absorption and efficacy.
Objectives:
To observe the efficacy and the adverse effects of methotrexate iontophoresis as compared to oral methotrexate therapy in the treatment of hyperkeratotic palmoplantar eczema.
Methodology:
This unblinded, randomized, parallel-group controlled trial included 88 patients. Group A (n = 44, 50%) received weekly iontophoresis of injectable methotrexate for four weeks, then biweekly for up to three months. Group B (n = 44, 50%) received oral methotrexate (7.5 mg/week) with gradual dose increases. Efficacy was assessed using Hand Eczema Severity Index (HECSI) scores, digital photography, and follow-up evaluations conducted three months after study completion.
Results:
Both groups showed significant improvement in HECSI scores (P < 0.05) for palms and soles, with no statistical difference in percentage improvement. Group A reported cutaneous side effects like blistering and itching, while Group B had systemic side effects, including headache, nausea, and elevated liver enzymes. Relapse rates were 9.1% (n = 4) in Group A and 2.27% (n = 1) in Group B.
Conclusions:
Iontophoretic delivery of methotrexate in palmoplantar hyperkeratotic eczema was equally effective as oral methotrexate.
