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IRCT20240304061158N5 IRCT 2025-10-27 Shahed University Evaluation of the therapeutic effect of LeishG1 topical cream for the treatment of patients with cutaneous leishmaniasis caused by Leishmania tropica Evaluation of the therapeutic effect of topical LeishG1 cream combined with intralesional injection of meglumine antimoniate (Glucantime) compared to the control group (intralesional injection of Glucantime and topical placebo cream) for the treatment of patients with cutaneous leishmaniasis caused by Leishmania tropica in humans based on a randomized, double-blind clinical trial 2026-01-21 anticipated 140 Recruiting https://irct.ir/trial/86851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After identifying eligible patients, random allocation into two groups will be performed using a block randomization method. Four blocks will be generated with combinations of codes AABB, ABAB, ABBA, BAAB, BABA, and BBAA corresponding to the drug and placebo groups. The blocks will then be randomly selected using the RAND function in Microsoft Excel until the desired sample size is achieved. Group assignment will be carried out using 154 opaque sealed envelopes labeled externally with the group number and containing information about the intervention type inside each envelope, Blinding description: Both the drug and placebo are packaged identically and can only be distinguished by a code for identification. This blinding procedure is applied to patients, investigators, clinical monitors, outcome assessors, and data analysts. At the end of the study, following final data analysis, the codes will be unblinded. 3 Cutaneous leishmaniasis caused by Leishmania tropica. 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 injection once a week for a maximum of 12 weeks, along with treatment with LeishG1 cream (produced by Behpad Teb Iranian Company) twice a day for 3 months, applied as a thin layer on the lesion, the size of a knuckle. Intervention 2: Control group: 70 patients with skin lesions caused by Leishmania tropica, treated with meglumine antimonate according to the national protocol in the form of intralesional injection once a week for a maximum of 12 weeks, along with treatment with placebo cream (produced by Behpad Teb Iranian Company) twice a day for 3 months, applied as a thin layer on the lesion, the size of a knuckle. No - There is not a plan to make this available Justification or reason for not sharing IPD is Ethical consideration about patient information
public Azadeh Rashidi
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1417953836 +98 21 6641 9712 a.rashidi@shahed.ac.ir Shahed University scientific Dr. Mehdi Mohebali
Tehran, Poursina Street, Tehran University of Medical Sciences, School of Public Health
Tehran Iran (Islamic Republic of) 1471616381 +98 21 8895 1392 mohebali@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 12 years 60 years Both 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 B55.1 Cutaneous leishmaniasis Treatment - Drugs Placebo 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 injection once a week for a maximum of 12 weeks, along with treatment with LeishG1 cream (produced by Behpad Teb Iranian Company) twice a day for 3 months, applied as a thin layer on the lesion, the size of a knuckle. Control group: 70 patients with skin lesions caused by Leishmania tropica, treated with meglumine antimonate according to the national protocol in the form of intralesional injection once a week for a maximum of 12 weeks, along with treatment with placebo cream (produced by Behpad Teb Iranian Company) twice a day for 3 months, applied as a thin layer on the lesion, the size of a knuckle. 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. 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. Tehran University of Medical Sciences Shahed University Tehran University of Medical Sciences Approved 2025-10-06 Research Ethics Committees of School of Public Health & Allied Medical Sciences- Tehran University o Ethics Committee in Biomedical Research, Tehran university of medical sciences - Keshavarz Boulevard - Intersection of Qods Street - Central Building of Tehran University of Medical Sciences - 6th Floor - Room 604 Tehran Tehran Iran (Islamic Republic of)