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

Recruiting Phase 3 Interventional 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.
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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
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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.

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, …
Contacts

Suzette Sabine Kämink

+31643690015

s.s.kamink@gmail.com

CONTACT

Koert Ritmeijer

+31 6 24453143

koert.ritmeijer@oca.msf.org

CONTACT