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Can a drug and heat combo beat a parasitic skin disease?

NCT ID NCT04268524

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

645 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 2026

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

6 years and older

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: * 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

  • Bolan Medical Complex Hospital

    Quetta, Balochistan, Pakistan

  • Kuchlak Primary Health Care Centre (MCH), Kuchlak, Pakistan

    Quetta, Balochistan, Pakistan

  • Shaheed Mohtarma Benazir Bhutto General Hospital

    Quetta, Balochistan, Pakistan