Introduction
leishmaniasis, rash
VISCERAL LEISHMANIASIS, POST-KALA-AZAR DERMAL LEISHMANIASIS, DISEASE, LEISHMANIASIS, SECONDARY
Post-kala-azar dermal leishmaniasis (PKDL) is characterized by a skin rash presenting months or even years after treatment of visceral leishmaniasis (VL) caused by More recently, a Phase III clinical trial showed PKDL rates of 20.9% for VL patients in Sudan and Ethiopia treated with the current standard of care, a sodium stibogluconate (SSG) and paromomycin (PM) combination, and 4.4% for VL patients treated with a miltefosine and paromomycin combination, after 6 months of follow-up [Despite the disease being a manifestation of There are no conclusive studies on treatment of PKDL in Africa. Usually, PKDL treatments are longer than those for VL, mainly because lesions may take a long time to heal. Studies with a limited number of patients with PKDL in Sudan showed that liposomal amphotericin B (LAmB, 50 mg/kg total dose) had an efficacy of 83% (10/12 patients) [Studies in India and Bangladesh have demonstrated that phlebotomine sandflies can become infected with A suitably safe treatment that can be administered on an out-patient basis, or that requires only a short hospitalization period, is needed. In addition, data on drug exposure in the skin is needed to guide better choices of therapy for PKDL. LAmB in monotherapy and in combination with MF for short courses have been successful for the treatment of PKDL in the Indian subcontinent [MF is orally available and has effectively been used in the treatment of various dermal presentations of leishmaniasis [The primary objective of this study was to assess the safety and efficacy of PM combined with MF and LAmB combined with MF for the treatment of patients with PKDL in Sudan who present the disease progressing for more than 6 months, or with grade 3 lesions. A secondary objective was the assessment of skin and plasma concentrations of PM, LAmB, and MF. In addition, an exploratory analysis was done to identify potential risk factors associated with the treatment outcome. This strategy seeks to reduce the hospitalization period, extend the oral treatment to achieve appropriate exposure and satisfactory efficacy levels, and reduce the risk of resistance development. In addition, parasite dynamics in skin and blood were assessed by qPCR, and immunological markers were investigated before, during, and after treatment. These are outside the scope of the present manuscript and will be presented in another article.