Cutaneous leishmaniasis caused by Leishmania tropica. Cutaneous leishmaniasis
Conditions
Interventions
Intervention 1: Intervention group: 70 patients with skin lesions caused by Leishmania tropica, treated with meglumine antimonate according to the national protocol in the form of intralesional inject
Sponsors
Shahed University
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: Presence of an active cutaneous leishmaniasis lesion caused by Leishmania tropica, confirmed by parasitological examinations including direct smear and PCR Age between 12 and 60 years Awareness of the study procedures Willingness to participate in the study and signing of the informed consent form A maximum of 5 lesions per participant The largest diameter of cutaneous lesions less than or equal to 5 cm
Exclusion criteria
Exclusion criteria: Suspected individuals to the disease Absence of Leishmania bodies in cutaneous lesions Number of lesions more than 5 Atypical lesions or lesions located in sensitive areas of the body (e.g., lips, ears, joints) Mean ulcer size greater than 5 cm Lipoid or treatment-resistant forms of cutaneous leishmaniasis Pregnant and lactating women Concurrent use of other anti-leishmanial medications Presence of dermatologic diseases such as eczema, psoriasis, lupus, pemphigus, fungal infections, and similar conditions Participation in the same research project
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete re-epithelialization: an skin lesion that is completely re-epithelialised by the end of the 12-week treatment period (i.e., 3 months). Timepoint: Two weeks and one, two, and three months after the initiation of treatment. Method of measurement: The percentage of re-epithelialization of the lesion(s) will be calculated by comparing the ulcer size at baseline to the ulcer size at follow-up visits. Measurements will be taken in two perpendicular directions using a caliper or ruler. The ulcer area will be calculated using the elliptical area formula. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events. Timepoint: Days 0, 14, 28, two months, and three months after the initiation of treatment. Method of measurement: Follow-up and examination.;Relapse. Timepoint: Three to six months after the end of treatment. Method of measurement: An skin lesion that reaches 100% re-epithelialization by day 90 and subsequently relapse by day 180. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzadeh Rashidi
Shahed University
Outcome results
None listed