Long-term efficacy of single-dose radiofrequency-induced heat therapy vs. intralesional antimonials for cutaneous leishmaniasis in India

Background Radiofrequency-induced heat therapy (RFHT) has been found to be safe and effective against cutaneous leishmaniasis (CL) in the short term, but its long-term efficacy is unclear. Objectives To compare the long-term efficacy of RFHT vs. intralesional sodium stibogluconate (SSG) injections in the treatment of CL in India. Methods One hundred patients with a confirmed diagnosis of CL were randomly assigned in a 1:1 ratio to receive topical RFHT for 3060s or seven intralesional injections of SSG (50mgcm2 of lesion). Improvement and recurrence were monitored every 15days after the initiation of treatment for 4months and then at 5, 6, 9, 12 and 18months post-treatment; the rates of complete cure were compared. Results Lesions were healed in 47 out of 50 patients (94%) in the RFHT group and in 46 out of 50 patients (92%) in the SSG group at week 12. Time to complete healing was comparable in the two groups. At 6months post-treatment, cure rates in the RFHT and SSG groups were 98% [95% confidence interval (CI) 94100%] and 94% (95% CI 86100%), respectively. Age, sex and lesion size or number had no effect on cure rates. No relapse of infection was recorded in cured patients in either group up to 1218months after initiation of treatment. Skin biopsies of cured lesions in eight out of eight (100%) patients from the RFHT group and three of three from the SSG group at 12months showed minimal fibrosis and were negative for Leishmania tropica by polymerase chain reaction test. Conclusions A single application of RFHT is safe, cosmetically acceptable and effective in inducing a long-term cure of CL.