Abstract Background Cutaneous leishmaniasis (CL) is a major public health concern, particularly in Ethiopia, where about 40,000 new cases occur annually, predominantly caused by Leishmania aethiopica. Clinical phenotypes include localized CL (LCL), mucocutaneous leishmaniasis (MCL), and diffuse CL (DCL). Objectives Despite the high disease burden, treatment options and high-quality data on treatment outcomes remain limited. We evaluated the effectiveness of standard treatments in Ethiopia to inform future clinical trials. Methods We conducted an observational cohort study of patients with parasitologically confirmed cutaneous leishmaniasis at two specialized dermatology referral hospitals. Clinical and patient-reported outcomes were assessed at baseline and at standardized times during follow-up. The primary clinical outcome measure (“cure”) was complete re-epithelialization or flattening of the index lesion at Day 90. Patient-reported outcomes were assessed using both skin-specific and general quality of life scores. Results We enrolled 666 participants from April 2022 to October 2023. The median age was 20 years (IQR: 14-35) and 405 were male (60.8%). More than half (55.9%) had previously received traditional treatment for CL. Most participants had LCL (58.6%) or MCL (35.2%). Intramuscular sodium stibogluconate 20mg/kg/day was the most frequently used systemic therapy, either alone or in combination with lesion-directed therapy (cryotherapy or intralesional sodium stibogluconate). At Day 90, 28.3% of participants with LCL, 23.5% with MCL, and 8.3% with DCL were cured. By Day 90, all patient-reported outcomes of skin health improved for those with LCL or MCL, but skin and CL-related quality of life scores did not improve for DCL. Most participants (81.4%) experienced at least one clinical adverse event and 7.2% had abnormal laboratory findings during treatment. Conclusions Current treatment strategies have low cure rates in Ethiopia. Well-designed randomized controlled trials are urgently needed to improve management of CL caused by L. aethiopica.
Doni et al. (Sat,) studied this question.