Safety Evaluation of Topical Application of Nano-Liposomal Amphotericin B (Sinaampholeish)
Phase 1
- Conditions
- Cutaneous leishmaniasis.Cutaneous leishmaniasis
- Registration Number
- IRCT20081130001475N12
- Lead Sponsor
- eglected Diseases Initiative
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
Healthy volunteer
aged between 18-65
willingness to participate in the study and signing the informed consent form
Exclusion Criteria
Any disease or illness according to subject history
Mentally ill based on physician diagnosis
participating in other concurrent trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Erythema. Timepoint: Daily evaluation after the 1st day of intervention to 7th day. Method of measurement: clinical exam.;Pruritus. Timepoint: Daily evaluation after the 1st day of intervention to 7th day. Method of measurement: clinical Exam.
- Secondary Outcome Measures
Name Time Method Any reported adverse events. Timepoint: Daily evaluation after the 1st day of intervention to 7th day. Method of measurement: Participants history.