Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
Recruiting
Phase 3Interventional Study
Old World Cutaneous Leishmaniasis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
832 (estimated)
Sponsor
Medecins Sans Frontieres, Netherlands · Other
Who this trial is looking for
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randomised control clinical trial to evaluate miltefosine, thermotherapy and the combination miltefosine-thermotherapy are effective, safe and tolerable alternative treatment options to treat cutaneous leishmaniasis caused by L. tropica, in Pakistan compared to the standard of care.
Trial Locations
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Eligibility Criteria
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, …
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.
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 \<10years 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 excipients
* 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
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