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
Evaluation of the therapeutic effect of intralesional Glucantime® injection combined with topical LeishG1 cream compared to intralesional Glucantime® injection with topical placebo cream on the cutaneous lesions of patients with CL caused by L.tropica
Design
Randomized, controlled clinical trial with parallel groups, double-blind, Phase 3 on 140 samples. Randomization is performed using the RAND function in Microsoft Excel.
Settings and conduct
This clinical trial will be conducted in Mashhad on eligible patients with active CL caused by L.tropica. Patients will be randomly assigned to two groups using randomised blocks, and the creams will be supplied in the same packaging with an identifiable code only. The subjects, the clinical caregiver and the outcome assessor will be blinded to the type of intervention. The treatment process includes intralesional injection of Glucantim and topical cream application for three months, and the epithelialisation process and side effects will be assessed at specific times.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: active cutaneous leishmaniasis lesion caused by Leishmania tropica, age 12-60 years, a maximum of 5 lesions per participant, the largest diameter of lesions less than 5 cm.
Exclusion Criteria: atypical lesions or lesions located in sensitive areas of the body, lopoid or treatment‑resistant forms of CL, pregnant or lactating women.
Intervention groups
Group 1: Treatment with Glucantime® by intralesional injection once a week for a maximum duration of 12 weeks, combined with topical application of LeishG1 cream twice daily on the lesion for 3 months.
Group 2: Treatment with Glucantime® by intralesional injection once a week for a maximum duration of 12 weeks, combined with topical application of placebo cream twice daily on the lesion for 3 months.
Main outcome variables
Re-epithelialization of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240304061158N5
Registration date:2025-10-27, 1404/08/05
Registration timing:prospective
Last update:2025-10-27, 1404/08/05
Update count:0
Registration date
2025-10-27, 1404/08/05
Registrant information
Name
fariba nemati
Name of organization / entity
Behpad Teb Iranian
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 6890
Email address
info@behpadti.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2028-07-22, 1407/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the therapeutic effect of LeishG1 topical cream for the treatment of patients with cutaneous leishmaniasis caused by Leishmania tropica
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 12 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
140
More than 1 sample in each individual
Number of samples in each individual:
5
The number of skin lesions is up to 5 per participant.
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Public Health & Allied Medical Sciences- Tehran University o
Street address
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
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2025-10-06, 1404/07/14
Ethics committee reference number
IR.TUMS.SPH.REC.1404.169
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis caused by Leishmania tropica
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
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 outcomes
1
Description
Adverse events
Timepoint
Days 0, 14, 28, two months, and three months after the initiation of treatment
Method of measurement
Follow-up and examination
2
Description
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.
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center of Martyrs of Health-Mashhad
Full name of responsible person
Dr. Vahid Mashayekhi
Street address
Mashhad, Moalem Blvd., Moalem 75, Moalem 75.6
City
Mashhad
Province
Razavi Khorasan
Postal code
mashayekhiv@mums.ac.
Phone
+98 51 3509 2770
Email
mashayekhiv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Tooba Ghazanfari
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Email
irrc@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
60
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Mohebali
Street address
Tehran, Poursina Street, Tehran University of Medical Sciences, school of Public Health
City
Tehran
Province
Tehran
Postal code
1471616381
Phone
+98 21 8895 1392
Email
mohebali@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Azadeh Rashidi
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Email
a.rashidi@shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Mohebali
Position
Professor (The first of principle investigator)
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Tehran, Poursina Street, Tehran University of Medical Sciences, School of Public Health
City
Tehran
Province
Tehran
Postal code
1471616381
Phone
+98 21 8895 1392
Email
mohebali@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Azadeh Rashidi
Position
master of science
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Email
a.rashidi@shahed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD