Clinical trial Recruiting at 1 site Interventional Ages 12 to 60

Using thermotherapy at health centers to treat skin leishmaniasis in Ethiopia

Official title: Feasibility of Integrating Thermotherapy (TT) for Treatment of Cutaneous Leishmaniasis Into the Primary Healthcare Facilities in East Gurage Zone, Ethiopia

Run by Armauer Hansen Research Institute, Ethiopia · NCT06746350 · Data updated 2026-11-12

This study tests whether thermotherapy using the ThermoMed device can be feasibly used in primary care to treat cutaneous leishmaniasis in Ethiopia and sees how well it works for people in the Sodo area.

More Cutaneous Leishmaniasis trials

Quick facts

Study typeInterventional
Ages12 Years to 60 Years
SexAll
Enrollment103 (estimated)
SponsorArmauer Hansen Research Institute, Ethiopia
Academic / other
Locations1 site (Addis Ababa)
StatusRecruiting
StartedApril 24, 2025
Main results expectedMarch 31, 2027
Study endsNovember 30, 2027
Registry record updatedOctober 16, 2026
Trial IDNCT06746350 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults and adolescents aged 12–60 with eligible CL lesions, treated at participating health centers in Sodo and South Sodo districts.

Probably not a fit

Patients with lesions outside the eligible size/location criteria or who cannot complete follow-up may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project investigates the feasibility of delivering thermotherapy for cutaneous leishmaniasis within primary health care facilities in the Sodo and South Sodo districts of Ethiopia. It uses a phased approach to develop staff training, pilot the intervention, and assess feasibility, acceptability, and appropriateness, with a comparison group at centers that do not currently offer thermotherapy. Participants with CL lesions receive a ThermoMed treatment (50°C for 30 seconds) and are followed for up to 90 days to monitor response. Enrollment targets up to 20 CL patients in the pilot phase, with ongoing monitoring and process evaluation to inform scalability. The study emphasizes integration into existing PHC workflows and resource considerations within the local health system.

Why it matters

Potential benefit: If successful, thermotherapy could provide a practical, scalable treatment option for cutaneous leishmaniasis in primary care settings, improving access and outcomes.

How similar studies have gone: Thermotherapy has shown promise in other settings, but its feasibility in Ethiopian primary care and integration into PHC services is being evaluated in this study.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Males and females aged ≥12 and ≤60 years old.
* Patient has a lesion that satisfies the following criteria:

  * Lesion size \< or = 4 cm (longest diameter).
  * Not located adjacent to ear, nose, eyes, lips, or close to mucosal membranes.
  * Patient with \< or = 4 CL lesions
* Patient able to give written informed consent.

Exclusion Criteria:

* Any condition that prevents the patient from following the study treatment and/or the follow-up

Where it's running

  • CDT-Africa
    Addis Ababa, Ethiopia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.