Zoonotic cutaneous leishmaniasis. Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention 1: Control group: Standard treatment with Glucantime (injection) - Positive control: Intralesional injection in 4 areas around the wound to the extent that the wound area turns white (1-2
Sponsors
Zoonoses Research Center (Common Human and Animal Diseases), Tehran university of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1- Individual consent and initial agreement to continue treatment 2- Examination of the presence of Leishmaniasis in the lesion using conventional sampling methods and microscopic confirmation 3?? - Individuals between the ages of 15-45 4- Active open lesions including ulcers (for 3 to 6 months) and the size of the ulcer is less than 5 cm 5- Number of skin lesions (maximum three to four lesions per patient) 6- Iranian citizen 7- The causative agent is Leishmania major.
Exclusion criteria
Exclusion criteria: Pregnant women People with immunodeficiency and underlying diseases and high-risk individuals People with old lesions (more than 5 months) or infected and recurrent People who have previously been treated with anti-leishmanial drugs Previous history of leishmaniasis Atypical forms of the disease and purulent lesions Presence of wounds or lesions in sensitive areas such as the eyelids History of allergy to honey products Users of immunosuppressive drugs Regional adenopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement rate and reduction of skin lesions caused by Leishmania major using the designed dressing. Timepoint: Measurement of the wound and the presence of parasites in the lesion before treatment, one month, three months, and six months after treatment. Method of measurement: Measuring the dimensions of the lesion with calipers, taking a sample, and examining the presence of parasites using molecular methods (Real time PCR) at the lesion site. | — |
Secondary
| Measure | Time frame |
|---|---|
| Possibility of causing skin sensitivity and inflammatory reactions, no scarring after the lesion heals. Timepoint: During treatment and after the lesion heals. Method of measurement: Inflammatory response test (cytokine measurement), careful observation of the site of the previous lesion for the presence or absence of scarring. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohsen Mahmoudi
Tehran University of Medical Sciences
Outcome results
None listed