Can a drug and heat combo beat a parasitic skin disease?
NCT ID NCT04268524
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial tests whether a drug called miltefosine, heat therapy (thermotherapy), or both together can safely and effectively treat skin lesions caused by the Leishmania tropica parasite in Pakistan. About 645 adults with up to four skin sores will be randomly assigned to one of four treatment groups and followed for several months. The goal is to see if these newer approaches work as well as or better than the current standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- miltefosine combined with thermotherapy (heat treatment)
- What this could lead to
- If successful, this could offer simpler, safer treatment options for a disfiguring skin disease, reducing reliance on painful injections.
- What could go wrong
- This is an early-stage trial in a single country, and the combination therapy may cause side effects or not work better than existing 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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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645 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Jun 2026
- Lead sponsor
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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
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6 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Male and female patients with clinical and laboratory confirmed CL, and who can be treated with localised intralesional antimonial injections and/or thermotherapy: * lesion size ≥0.5 cm and ≤4 cm * not located on the ear, nose, near to the eye or mucosal membranes, on joints, or on a location that in the opinion of the principle investigator (PI) is difficult to apply thermotherapy (TT) or intralesional (IL) injections * patient with ≤4 lesions * duration of lesions less than five months by patient history * Patients who have signed the informed consent form. After adaptation : (end Dec 2024) one eligible criteria changed : age from 10 to 6; all children from 6 years and older are eligible Exclusion Criteria: * Pregnant women and breast feeding women * Non-pregnant women in reproductive age refusing effective (injectable) contraception for a period of five months * Patients \<6years old * Patients who cannot be treated with localised IL antimonial injections or TT (patients with more than 4 lesions, lesions \>4cm in diameter, or located on joints, lips, nose, ears or near eyes) * History of clinically significant medical problems or treatment that might interact with the study treatment and interact with wound healing, such as diabetes, vascular diseases and any immunocompromising condition * Within eight weeks of trial D1 received treatment for leishmaniasis with any medication * History of known or suspected hypersensitivity of idiosyncratic reactions to trial medication or experiments * Has laboratory values at screening: serum creatinine above normal level; ALT 3 times above normal range * Patient who is not willing to attend the trial visits, or is not able to comply with follow-up visits up to three months. * Known history of drug addiction and/or alcohol abuse After adaption (end Dec 2024) one exclusion criteria changed: age from 10 to 6 yrs, Children \< 6 years are excluded \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bolan Medical Complex Hospital
Quetta, Balochistan, Pakistan
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Kuchlak Primary Health Care Centre (MCH), Kuchlak, Pakistan
Quetta, Balochistan, Pakistan
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Shaheed Mohtarma Benazir Bhutto General Hospital
Quetta, Balochistan, Pakistan