1. Home
  2. Approved trials
  3. » فارسی

Comparing the effectiveness of Leish G1 cream with Glucantime and simultaneous use of Glucantime and LeishG1 with Glucantime and placebo on the improvement of cutaneous leishmaniasis

Protocol summary

Study aim
Comparing the effectiveness of LeishG1 cream with Glucantime and simultaneous use of Glucantime and LeishG1 with Glucantime and placebo on the improvement of cutaneous leishmaniasis(CL)
Design
The phase 3 Clinical trial with a control group, with parallel groups, double-blind, randomized, on 120 patients.
Settings and conduct
120 patients with CL lesion were randomly divided into four groups of 30 people and take medicine or placebo for 3 months. 1: LeishG1 cream at the lesion site 2: Glucantime at the lesion site 3: Glucantime + LeishG1 cream at the lesion site 4: Glucantime + topical placebo cream at the lesion site study location: Isfahan's Skin diseases and Leishmaniasis Research Center Patients and the doctors will be blinded about the drug and the placebo. One group does not receive an injection, so blinding at the participant level is not possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Maximum 4 lesions per person Exclusion criteria: Lesions on the face or ears, lymphadenitis infection, receiving any other treatment, pregnancy and lactation, any other skin diseases. Withdrawal criteria: Skin sensitivity and irritation
Intervention groups
Intervention 1 receive the intervention of LeishG1 cream twice a day. Intervention 2 receive glucantim injection according to the standard protocol. Intervention 3 receive glucantim injections according to the standard protocol and LeishG1 cream twice a day, simultaneously . Intervention 3 receive glucantim injections according to the standard protocol and placebo cream twice a day, simultaneously. All four groups include patients with CL
Main outcome variables
Comparison of the effectiveness of LeishG1 cream with glucantim and simultaneous use of glucantim and LeishG1 with glucantim and placebo on lesion size, time to cure and adverse reactions (edema, itching, burning, local pain, erythma)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240304061158N1
Registration date: 2024-07-22, 1403/05/01
Registration timing: registered_while_recruiting

Last update: 2024-07-22, 1403/05/01
Update count: 0
Registration date
2024-07-22, 1403/05/01
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
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Leish G1 cream with Glucantime and simultaneous use of Glucantime and LeishG1 with Glucantime and placebo on the improvement of cutaneous leishmaniasis
Public title
The effect of LeishG1 cream on cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the eligible patients, the patients will be randomized into 4 study groups using the randomization method based on block randomization. In this way, 24 blocks are formed by combining codes A, B, C, D, related to intervention groups 1 to 4. Then the blocks will be randomly selected based on the rand function from Excel until the final volume of the sample is reached. Grouping is done by determining 120 non-transparent envelopes, which have the group number on the envelope and the type of intervention inside the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the drug and the placebo are packed in the same package and can only be identified by the code and in this way, blinding has been done for the patient, the plan executive, the clinical care provider, the outcome assessor and the data analyst. At the end, after the final analysis of the data, the codes will be opened.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran (routing)
City
tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-01-08, 1402/10/18
Ethics committee reference number
IR.SHAHED.REC.1402.129

Health conditions studied

1

Description of health condition studied
cutaneous leishmaniasis lesion
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis

Primary outcomes

1

Description
Lesion 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 outcomes

1

Description
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

Intervention groups

1

Description
Intervention 1: A number of 30 patients with small skin lesions (≥5cm), will be treated with LeishG1 cream produced by Behpad Teb Company, applied twice a day in a fingertip unit as a thin layer on the wound for 3 months.
Category
Treatment - Drugs

2

Description
Control group: 30 patients with small skin wounds (≥5cm), will be treated with Glucantim intralesional injection (provided by Sanofi-Aventis) according to the standard protocol.
Category
Treatment - Drugs

3

Description
Intervention group 3: 30 patients with small skin wounds (≥5cm), will be treated with Glucantim intralesional injection (provided by Sanofi-Aventis company) according to the standard protocol + LeishG1 cream from Behpad Teb company, twice a day in a fingertip unit as a thin layer is applied to the wound.
Category
Treatment - Drugs

4

Description
Control group: 30 patients with small skin wounds (≥5cm), will be treated with Glucanthim intralesional injection (provided by Sanofi-Aventis company) according to the standard protocol + placebo cream from Behpad Tab company twice a day i in a fingertip unit as a thin layer is applied to the wound.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan's Skin diseases and Leishmaniasis Research Center
Full name of responsible person
nazli ansari
Street address
Isfahan, Khorram St., after Shahidan Crossroads, Hazrat Sedigheh Tahereh Comprehensive Rehabilitation and Medical Center, Skin diseases and Leishmaniasis Research Center
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 3736
Fax
+98 31 3337 3736
Email
nazli_md@hotmail.com
Web page address
https://sdlrc.mui.ac.ir/fa/aboutus

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behpad Teb Iranian
Full name of responsible person
Fariba Nemati
Street address
Tehran, 20th km of Damavand Road, Pardis Technology Park, Danesh 4, Fanavaran Bldg, Unit 22
City
tehran
Province
Tehran
Postal code
1654120611
Phone
+98 21 6642 6890
Fax
+98 21 4066 0468
Email
info@behpadti.com
Web page address
https://behpadti.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behpad Teb Iranian
Proportion provided by this source
75
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

2

Sponsor
Name of organization / entity
Shahed university Immune Response Regulation Research Center
Full name of responsible person
Azade Rashidi
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
Fax
+98 21 6641 9752
Email
immunoreg@shahed.ac.ir
Web page address
https://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 Immune Response Regulation Research Center
Proportion provided by this source
23
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

3

Sponsor
Name of organization / entity
Isfahan's Skin diseases and Leishmaniasis Research Center
Full name of responsible person
zabihalla shahmoradi
Street address
Isfahan, Khorram St., after Shahidan Crossroads, Hazrat Sedigheh Tahereh Comprehensive Rehabilitation and Medical Center, Skin diseases and Leishmaniasis Research Center
City
Isfahan
Province
Isfehan
Postal code
81876-98191
Phone
+98 31 3335 9090
Fax
+98 31 3337 7766
Email
shahmoradi@med.mui.ac.ir
Web page address
https://sdlrc.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan's Skin diseases and Leishmaniasis Research Center
Proportion provided by this source
2
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
Isfahan Skin diseases and Leishmaniasis Research Center
Full name of responsible person
Nazli Ansari
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
dermatologist
Street address
Khorram St., after Shahidan Crossroads, Hazrat Sedigheh Tahereh Comprehensive Rehabilitation and Medical Center, Skin diseases and Leishmaniasis Research Center
City
Isfahan
Province
Isfehan
Postal code
81876-98191
Phone
+98 31 3335 9090
Email
nazli_md@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Skin diseases and Leishmaniasis Research Center
Full name of responsible person
Zabihollah Shahmoradi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
dermatologist
Street address
Khorram St., after Shahidan Crossroads, Hazrat Sedigheh Tahereh Comprehensive Rehabilitation and Medical Center, Skin diseases and Leishmaniasis Research Center
City
Isfahan
Province
Isfehan
Postal code
81876-98191
Phone
+98 31 3335 9090
Email
shahmoradi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Immunoregulation Research Center
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
Fax
+98 21 6641 9752
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
ٍEthical consideration about patient information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...