Ketoconazole for Cutaneous Leishmaniasis in the Context of Drug Shortages: A Case Report from Madre de Dios, Peru.

BACKGROUND

Cutaneous leishmaniasis (CL) is a neglected tropical disease endemic in the Peruvian Amazon. First-line treatment with pentavalent antimonials was unavailable in Madre de Dios, Peru in early 2024 due to a supply-chain crisis. Oral ketoconazole has shown in vitro activity and modest efficacy in small clinical series as a salvage therapy, though it is not established as standard treatment.

CASE PRESENTATION: A 41-year-old woman (body mass index 48 kg/m²) from a rural community in Madre de Dios presented with two ulcerative lesions (0.8 cm and 1.2 cm) on the dorsal aspect of the left little finger, of 4 weeks' duration. CL was confirmed by Giemsa smear and PCR as Leishmania (Viannia) sp. (~98% homology with local reference strains). In the absence of antimonials, and after informed consent, she received oral ketoconazole 200 mg twice daily for 6 weeks. By week 4, total lesion area had contracted by ~65%, and follow-up polymerase chain reaction (PCR) turned negative. Near-complete re-epithelialization was achieved by week 6. No hepatotoxicity or serious adverse events occurred; only mild transient nausea was reported. At 12 months' follow-up, there was no relapse.

CONCLUSIONS

In this single-patient experience, oral ketoconazole (200 mg every 12 hours for 6 weeks) appeared to be an effective and well-tolerated alternative for CL during an antimonial shortage. Given the possibility of spontaneous healing in CL and the lack of a control group, controlled clinical trials are warranted before broader adoption.