About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- drug: miltefosine with thermotherapy