Protocol summary

Study aim
Effect of topical sodium chlorite (NaClO2) on the treatment course of lupoid leishmaniasis: A clinical trial
Design
This clinical trial with a before and after treatment design of 20 patients with lupoid leishmaniasis were assigned base on community-based setting.
Settings and conduct
The study population will be selected from the patients with lupoid leishmaniasis referring to Imam Reza Hospital, Mashhad, Iran, and will be administered topical sodium chlorosome for treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of a history of positive smear for leishman body or pathology; clinical features associated with lesion of lupoid leishmaniasis. Exclusion criteria: Using alternative treatments 2 months prior or during the intervention, pregnancy or breastfeeding.
Intervention groups
The intervention group were subjected to topical sodium chlorosome (including 12 mM NaClO2 with 10-11 PH and 2.4% glycerol with brand name of Oxoferin) twice a day for 6 weeks.
Main outcome variables
The evaluation and comparison of the therapeutic responses based on the photos taken of lesion before and 6 weeks after the treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190114042356N1
Registration date: 2019-02-02, 1397/11/13
Registration timing: prospective

Last update: 2019-02-02, 1397/11/13
Update count: 0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Vahid Mashayekhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 5215
Email address
mashayekhiv1@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical sodium chlorite (NaClO2) on the treatment course of lupoid leishmaniasis: A clinical trial
Public title
The treatment of patients with lupoid leishmaniasis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of a history of positive smear for leishman body or pathology Clinical features associated with lesion of lupoid leishmaniasis
Exclusion criteria:
Using alternative treatments 2 months prior or during the intervention Pregnancy or breastfeeding
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.MUMS.REC.1394.357

Health conditions studied

1

Description of health condition studied
Lupoid leishmaniasis
ICD-10 code
B55.9
ICD-10 code description
Leishmaniasis, unspecified

Primary outcomes

1

Description
Therapeutic responses
Timepoint
before and 6 weeks after the treatment
Method of measurement
The photos taken of lesion

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group were subjected to topical sodium chlorosome (including 12 mM NaClO2 with 10-11 PH and 2.4% glycerol with brand name of Oxoferin) twice a day for 6 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Vahid Mashayekhi
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3606 5215
Email
mashayekhiv@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
913753459
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Mashayekhi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3606 5215
Email
mashayekhiv@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Mashayekhi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3606 5215
Email
mashayekhiv@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Mashayekhi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3606 5215
Email
mashayekhiv@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Vahid Mashayekhi provides the analysis code to the applicants via email: mashayekhiv@mums.ac.ir
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.
Comments
Loading...