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.
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
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)
Parallel
drug: miltefosine with thermotherapy
Combination productsee previous
The initial clinical cure rate in each study arm
Initial Cure: Ulcerated lesions: 100% re-epithelialization of the lesion(s) Non-Ulcerated lesions: flattening and/or no signs of induration of the lesion(s) by Day 91.
Adverse events
Frequency, severity and seriousness of AEs by treatment group
initial cure and no relapse
The proportion of patients in each study arm who have fulfilled the criteria of initial cure and have no relapse
100% re-epithelialized/ flattened
The number of patients with lesions 100% re-epithelialized/ flattened at each measurement time point.
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