Diagnosis of localized cutaneous leishmaniasis and treatment outcomes following carbon dioxide cryotherapy performed by health centre staff: A pilot implementation study in Ethiopia

@article{zewdu2026diagnosis,
  title = {{Diagnosis of localized cutaneous leishmaniasis and treatment outcomes following carbon dioxide cryotherapy performed by health centre staff: A pilot implementation study in Ethiopia}},
  author = {Feleke Tilahun Zewdu and Kassahun Alemu and Saba Lambert and Bisrat Misganaw and Zemed Biyazn Abebe and Eyob Fekadu Shegaw and Tedros Nigusse and Galana Mamo Ayana and Eshetu Molla and Rachel L. Pullan and Jennifer Palmer and Catherine Pitt and Yohannes Hailemichael and Michael Marks and Endalamaw Gadisa and Stephen L. Walker},
  journal = {PLOS Global Public Health},
  year = {2026},
  month = sep,
  doi = {10.1371/journal.pgph.0006930},
  url = {https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0006930},
  note = {CC BY 4.0},
}

TY  - JOUR
TI  - Diagnosis of localized cutaneous leishmaniasis and treatment outcomes following carbon dioxide cryotherapy performed by health centre staff: A pilot implementation study in Ethiopia
AU  - Feleke Tilahun Zewdu
AU  - Kassahun Alemu
AU  - Saba Lambert
AU  - Bisrat Misganaw
AU  - Zemed Biyazn Abebe
AU  - Eyob Fekadu Shegaw
AU  - Tedros Nigusse
AU  - Galana Mamo Ayana
AU  - Eshetu Molla
AU  - Rachel L. Pullan
AU  - Jennifer Palmer
AU  - Catherine Pitt
AU  - Yohannes Hailemichael
AU  - Michael Marks
AU  - Endalamaw Gadisa
AU  - Stephen L. Walker
PY  - 2026
DA  - 2026/09/09
JO  - PLOS Global Public Health
DO  - 10.1371/journal.pgph.0006930
UR  - https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0006930
AB  - In Ethiopia, the incidence of cutaneous leishmaniasis (CL) is estimated to range from 20, 000–30, 000 new cases due to Leishmania aethiopica. Children and young adults, in rural communities with limited access to health care are most affected. The current standard of care, pentavalent sodium stibogluconate is only administered in specialist centres, has limited effectiveness and is associated with severe adverse effects. Cryotherapy is recommended in national guidelines at the primary care level to treat uncomplicated CL, but is rarely available due to limited numbers of trained clinicians and lack of resources. We co-developed and evaluated a decentralised intervention, administered at a rural health centre, using carbon dioxide (CO2) cryotherapy, which is available for the treatment of cervical dysplasia. A pragmatic clinical trial design was used, providing training at the health centre that combined theoretical instruction with direct patient assessment. Study clinicians recruited patients with suspected CL who had a slit-skin smear performed with confirmation by expert microscopists. The diagnostic accuracy of trained clinical and laboratory staff at a rural health centre were compared to experts. Individuals aged ≥12 years with parasitologically confirmed uncomplicated CL received CO2 cryotherapy. Participants were followed until Day 90. Cure was defined as complete re-epithelialization of the index lesion. The study was registered in the Pan African Clinical Trials Registry with trial number PACTR202605616785682. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=41111. We trained seven clinicians and laboratory professionals at Keteteya Health Centre. Of 331 individuals who attended the clinic with skin disease, 158 (47.7%) were clinically diagnosed by trained clinical staff with CL. Overall 123 (78%) had laboratory confirmed CL and of these 85 (53.8%) received CO2 cryotherapy. By Day 90, 68 of 77 (88.3% (95% CI: 78.5–94.1%)) were cured. Adverse events were mild and transient, with no individual discontinuing treatment. Trained health centre clinical and laboratory staff were able to accurately diagnose CL. CO2 cryotherapy was safe and efficacious when administered by trained staff. A training programme to facilitate CO2 cryotherapy appears to be a feasible approach to decentralizing CL diagnosis and treatment to primary healthcare facilities in endemic areas of Ethiopia. Author summary: Cutaneous leishmaniasis (CL) is a neglected tropical disease (NTD) of the skin caused by species of the genus Leishmania. It is endemic in Ethiopia’s highland regions. Affected individuals often face significant barriers to accessing care due to the limited numbers of trained health professionals and long distances to diagnostic and treatment centres. Treatments for CL, including sodium stibogluconate and liquid nitrogen cryotherapy, are challenging to implement in rural settings. Carbon dioxide cryotherapy is now widely available for cervical dysplasia in primary health centres in Ethiopia and could potentially be repurposed for the management of CL. Our study evaluated the efficacy of carbon dioxide cryotherapy for the treatment of CL when administered by trained health centre staff. Eighty-five individuals with confirmed CL were treated with carbon dioxide cryotherapy and 68 (88.3%) were healed at Day 90. These findings suggest that carbon dioxide cryotherapy is efficacious when administered by trained health centre staff. Controlled trials are warranted to confirm these findings and to inform implementation strategies.
SN  - 2767-3375
ER  -