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Heat treatment could bring leishmaniasis care to local clinics

NCT ID NCT06746350

Disease control Sponsor: Armauer Hansen Research Institute, Ethiopia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a device that heats skin lesions to 50°C for 30 seconds can effectively treat cutaneous leishmaniasis in primary health centers in Ethiopia. 103 patients aged 12 to 60 with up to four lesions will receive thermotherapy and be monitored for 90 days. The goal is to see if this simple heat treatment is practical, acceptable, and effective in a real-world setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Thermotherapy (heat treatment using ThermoMed device at 50°C for 30 seconds)
What this could lead to
If successful, this could show that heat therapy is a practical and effective way to treat skin leishmaniasis in local clinics, making treatment more accessible.
What could go wrong
This is a small feasibility study, not a large trial. The treatment may not work as well in real-world settings, and some patients may need repeat treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cutaneous leishmaniasis Hyperthermia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous leishmaniasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CDT-Africa

    RECRUITING

    Addis Ababa, Ethiopia

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