Clinical trial of efficacy of combination of topical liposomal Amphotericin B and meglumine antimoniate (Glucantime) the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica (Phase 3)
Phase 3
- Conditions
- Cutaneous leishmaniasis.Cutaneous leishmaniasis
- Registration Number
- IRCT201504211475N7
- Lead Sponsor
- MoH, EMRO/WHO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Male or female aged between 12 to 60 years.
Parasitologically proven CL due to L. tropica.
In general good health based on history and physical examination.
Number of lesion at most 5.
Lesion size less than 3 cm.
Signed informed consent voluntarily and knowingly**. ** Guardian’s signature for volunteer less than 18 years old.
Exclusion criteria:
Pregnancy
lactating women
Use of other types of treatment for CL.
Involvement in any other drug or vaccine trial during the study period.
Known heart, kidney, liver diseases based on history and physical exam.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete cure. Timepoint: at week 4, 8, and days 90 and 180. Method of measurement: measurement of lesion status.
- Secondary Outcome Measures
Name Time Method esion(s) partial cure. Timepoint: at week 4, 8 and days 90 and 180. Method of measurement: measurement of lesion size.