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Home > Scientific articles
2026-09-19

Thermotherapy compared with intralesional sodium stibogluconate for Leishmania aethiopica cutaneous Leishmaniasis in Ethiopia: A phase II randomized controlled trial

BMC Medicine

by Shumie G, Asefa A, Ayele AA, Bayissa A, Zewdu FT, Abitse A, Doni SN, Getachew A, Ketema W, Cherkose T, Hailu T, Nigusse T, Ayana GM, Shemeles M, Kassa FA, Achalu DL, Demisse M, Solana JC, Moreno J, Jira SC, Boni M, Arana B, Massebo F, Gadisa E. BMC Medicine 2026. doi:10.1186/s12916-026-05244-6

Summary: Management of cutaneous leishmaniasis (CL) in Ethiopia is constrained by limited therapeutic options and lack of local clinical trial evidence to guide routine care. The authors of this manuscript conducted a randomized controlled Phase II/III trial comparing a single thermotherapy session with weekly intralesional sodium stibogluconate (IL-SSGV) for 4–6 weeks, in 183 adults with parasitologically confirmed, uncomplicated localized CL. Health-related quality of life improved significantly in both arms post-cure. While per-protocol analysis revealed a statistically significant lower final cure rate for thermotherapy (39.2%) than IL-SSGV (57.6%), intention-to-treat efficacy was comparable (44.0% for thermotherapy and 52.2% for IL-SSGV). In resource-limited Ethiopian settings, thermotherapy, with its better adherence and acceptable safety profile, provides a pragmatic alternative where IL-SSGV access is constrained.

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Cutaneous leishmaniasis Africa

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