Using Ivermectin to treat skin lesions from Post-kala-azar Dermal Leishmaniasis
Assessing Safety and Efficacy of Repurposed Oral Ivermectin in PKDL Treatment
This study is testing if Ivermectin can help treat skin lesions in people with Post-kala-azar Dermal Leishmaniasis, a condition that can happen after a different type of leishmaniasis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06251739 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Ivermectin in treating Post-kala-azar Dermal Leishmaniasis (PKDL), a condition that often follows visceral leishmaniasis. The study will involve administering Ivermectin and Miltefosine to confirmed PKDL patients who are otherwise healthy except for their skin lesions. The trial is crucial as PKDL cases are rising, and effective treatments are currently lacking, which poses a risk for the transmission of the Leishmania donovani parasite. Participants will be required to provide informed consent to join the study.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with confirmed cases of PKDL who are otherwise healthy.
Not a fit: Patients who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of PKDL and reduce its transmission.
How similar studies have performed: While there is limited data on the use of Ivermectin for PKDL, the approach of repurposing existing medications for new indications is gaining traction in clinical research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed PKDL cases of either sex * Clinically healthy except for skin lesions * Voluntary participation through informed, voluntary written consent Exclusion Criteria: * Incompliance with any inclusion criteria * Pregnant/lactating women
Where this trial is running
Dhaka
- International Centre for Diarrhoeal Disease Research, Bangladesh — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Dinesh Mondal, MBBS,MD,PhD — International Centre for Diarrhoeal Disease Research, Bangladesh
- Study coordinator: Dinesh Mondal, MBBS,MD,PhD
- Email: din63d@icddrb.org
- Phone: +88 02 222277001-10
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.