Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10+
SponsorMedecins Sans Frontieres, Netherlands

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

Treatment groups

832 Participants
are divided into 4 treatment groups