The Efficacy of Co-administration of Topical Niosomal Dapsone Gel and Intralesional Injection of Glucantime in Cutaneous Leishmaniasis in Comparison with Cryotherapy Plus Intralesional Injection of Glucantime

Leishmaniasis exists in more than half of Iran provinces and more than 20,000 cases are reported annually. In the recent years, several therapeutic approaches such as topical and physical treatments have been investigated. In the present study, the efficacy of co-administration of topical Niosomal Dapsone gel and Glucantime intralesional injection has been evaluated. This randomized clinical trial was performed on patients with leishmaniasis admitted in Afzalipour hospital affiliated to Kerman University of Medical Sciences and Dadbin Health Center, Kerman/Iran. After taking informed consent, patients were divided into the two groups. The first group was treated with weekly intralesional injection of Glucantime plus cryotherapy every two weeks and the second group was treated with weekly intralesional injection of Glucantime plus niosomal Dapsone gel twice a day. The patients were treated for at most 16 weeks and monitored in the 4th, 8th, 12th and 16th weeks of treatment. Data were analyzed using Random effects mixed model, Man Whitney, t-test and Chi-square test. A total of 68 patients (33 males and 35 females) with mean age of 30.63± 18.10 years were participated in this study. From all lesions, 86.3% were in upper extremities and the rest were in lower extremities and 60.3% of lesions were ulcerative. After 16 weeks, 82.9% of Dapsone-received group showed complete response. There was no significant difference between the two groups in regard to the rate and duration of response to the treatment. Niosomal topical Dapsone gel, due to its fewer side effects, can be used efficiently as an alternative treatment for cryotherapy in cutaneous leishmaniasis, especially in parts covering cartilages or finger tips and in patients with dark skin.