New treatments for cutaneous leishmaniasis in Pakistan
Randomised, Open Label, Multicentre, Non-inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
This study is testing new treatments for cutaneous leishmaniasis in Pakistan to see if miltefosine, thermotherapy, or their combination can work better and be safer than the usual antimonial injections.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 832 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Medecins Sans Frontieres, Netherlands Academic / other |
| Locations | 2 sites (Kuchlagh, Balochistan and 1 other locations) |
| Trial ID | NCT04268524 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness, safety, and tolerability of miltefosine, thermotherapy, and their combination as alternative treatments for cutaneous leishmaniasis caused by Leishmania tropica in Pakistan. The study compares these new treatment modalities against the standard care, which primarily involves antimonial injections. The trial aims to provide evidence-based options for patients suffering from this condition, particularly in regions where alternative treatments are scarce. By exploring both topical and systemic approaches, the study seeks to improve cure rates and reduce scarring associated with the disease.
Who should consider this trial
Good fit: Ideal candidates include male and female patients with clinically and laboratory confirmed cutaneous leishmaniasis, having localized lesions that meet specific size and location criteria.
Not a fit: Patients with extensive lesions, those located on sensitive areas like the face, or those under 10 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide effective and accessible treatment options for patients with cutaneous leishmaniasis, particularly in resource-limited settings.
How similar studies have performed: While there is limited evidence on the effectiveness of thermotherapy for L. tropica, previous studies have shown variable success rates, indicating that this approach is promising yet not fully established.
Eligibility criteria
Show full inclusion / exclusion 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, 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. 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 \<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) * 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 excipients * 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
Where this trial is running
Kuchlagh, Balochistan and 1 other locations
- Kuchlak Primary Health Care Centre (MCH) — Kuchlagh, Balochistan, Pakistan (Recruiting)
- Shaheed Mohtarma Benazir Bhutto General Hospital — Quetta, Balochistan, Pakistan (Recruiting)
Study contacts
- Study coordinator: Suzette Sabine Kämink
- Email: s.s.kamink@gmail.com
- Phone: +31643690015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.