The effect of LeishG1 cream on cutaneous leishmaniasis
Phase 3
Recruiting
- Conditions
- cutaneous leishmaniasis lesion.Cutaneous leishmaniasisB55.1
- Registration Number
- IRCT20240304061158N1
- Lead Sponsor
- Behpad Teb Iranian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Maximum 4 lesions per person
Exclusion Criteria
Skin sensitivity and irritation due to drug use
Simultaneous use of other drugs
immunodeficiency disorders or the use of immunosuppressive drugs
Pregnancy and breastfeeding
?Skin disease such as eczema, psoriasis, lupus, pemphigus, fungal lesions, etc.
Mental disorders and severe mental illnesses such as depression and madness
Lesions on the face or ears
Lymphadenitis infection
History of any other treatment for the current infection during the past three months
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method esion healing. Timepoint: The primary outcome of this study is lesion healing that will be assessed by area measurement index, which will be measured at the beginning of treatment (day zero) and on days 14, 28, 60 and 90 after the intervention. Method of measurement: Lesion healing: an ulcer that is completely re-epithelialized on days 42 to 63 and remains so on (no relapse) on days 90 and 180-360. An ulcer that is less than 50% of the initial size on day 45 and is completely re-epithelialized on both days 90 and 180-360 (no relapse).
- Secondary Outcome Measures
Name Time Method Adverse events. Timepoint: Adverse reactions such as itching, redness, and burning are checked on days 14, 28, 60, and 90. Method of measurement: Doctor examination and patient report.