safety and efficacy comparison trial of topical nano-liposomal form of Amphotericin B with national standard treatment for cutaneous leishmaniasis caused by Leishmania major (Phase 3)
Phase 3
- Conditions
- Cutaneous Leishmaniasis.Cutaneous leishmaniasis
- Registration Number
- IRCT201612101475N11
- Lead Sponsor
- ational Institute for Medical Research Development (NIMAD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Males & females 12-60 years of age;Parasitologically proven CL caused by L. major (identification is done ?by using PCR); Otherwise healthy subjects on the basis of medical history; physical ?examination and results of blood test if requested by the physician; Ability to understand the principles of the trial and Signing an ?informed consent voluntarily and knowingly.?
Exclusion Criteria
Pregnant or lactating women; Concurrent or chronic illness based on previous history;Duration of lesion more than 3 months;Number of lesions more than 5;Ulcer size greater than 3 cm in their largest diameter; History of full course of standard treatment (antimonials); ?Involvement in any other drug or vaccine trial during the study period.?
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Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reepithelization of the lesions/Complete cure. Timepoint: Monthly. Method of measurement: lesion measurement/Digital photos.
- Secondary Outcome Measures
Name Time Method Partial cure : Decrease size of the lesions. Timepoint: Monthly. Method of measurement: lesion mesurement /Digital photos.