Kuchlak

Researchers are evaluating new treatment options for cutaneous leishmaniasis caused by Leishmania tropica in Pakistan. This Phase 3 clinical trial compares the effectiveness, safety, and tolerability of miltefosine, thermotherapy, and their combination against the current standard treatment with antimonial injections. The study aims to find alternative therapies that are effective and easier to administer, especially for patients who cannot receive antimonial treatment due to health concerns. The study involves three treatment groups: oral miltefosine, thermotherapy, and a combination of both. Thermotherapy requires only a single treatment session and may cause less scarring, while miltefosine is an oral medication that can be given in local health facilities. Combining the two treatments may provide added benefits by targeting parasites more effectively and potentially shortening the treatment duration. Each participant will receive one of these treatments and be monitored for their response. Participants will be followed for 91 days to assess the initial clinical cure rate and record any adverse events. During the study, patients will have clinical and laboratory evaluations to confirm diagnosis and monitor progress. Researchers will collect data on treatment effectiveness and safety to determine if these new options are non-inferior to standard care. The total participation duration includes treatment and follow-up visits for up to three months.