Clinical Research Directory

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. After adaptation : (end Dec 2024) one eligible criteria changed : age from 10 to 6; all children from 6 years and older are eligible 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 \<6years 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 experiments * 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 After adaption (end Dec 2024) one exclusion criteria changed: age from 10 to 6 yrs, Children \< 6 years are excluded \-