Investigation of the effect of of photodynamic therapy with methylene blue on the treatment of cutaneous leishmaniosis
Design
Clinical trial with no control group, no blinding and no randomization
Settings and conduct
This study is conducted on 8 patients (4 children and 4 adults) referring to the leishmaniasis clinic of Imam Reza and Ghaem hospitals and Abo-Bargh health center, whose diagnosis is based on the clinical observation of the lesion and positive smear for leishman body. Methylene blue solution is applied topically to the lesion and it is then exposed to a red LED lamp twice a week for 30 minutes for a maximum of 12 weeks. This study will have no blinding and randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: newly diagnosed localized cutaneous leishmaniasis; less than 12 weeks has elapsed since the onset of the lesion; no lesion on face; number of lesions is less than four; no sporotricoid form; size of lesion is less than 5 centimeters; the lesion is not on joints; urban leishmaniasis.
Exclusion criteria: pregnancy and breastfeeding; existence of serious or severe underlying diseases.
Intervention groups
Intervention group: In this group, methylene blue solution (50μL of 0.5% MB in water) is applied topically on the lesion (before prescribing methylene blue, if there is a crust in ulcerative lesions, it will be removed by curetting) and after 20 minutes of exposure to LED lamp (Red LED light, with 663 nm wavelength, 100mW / cm2) for 30 minutes, twice a week, for a maximum of 12 weeks.
Main outcome variables
Ulcer development and complete lesion epithelialization in ulcerative lesions; becoming flat and change in induration diameter in non-ulcerative lesions; diameter of induration and erythema; ulcer size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200803048289N1
Registration date:2020-08-31, 1399/06/10
Registration timing:registered_while_recruiting
Last update:2020-08-31, 1399/06/10
Update count:0
Registration date
2020-08-31, 1399/06/10
Registrant information
Name
Forough Rakhshanizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2406
Email address
rakhshanizadehf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-11-05, 1399/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of of photodynamic therapy with methylene blue on the treatment of cutaneous leishmaniosis
Public title
The effect of of photodynamic therapy with methylene blue on the treatment of cutaneous leishmaniosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed localized cutaneous leishmaniasis confirmed by smear Giemsa sample
Less than 12 weeks has elapsed since the onset of the lesion
No lesion on face
Number of lesions is less than four
No sporotricoid form
Size of lesion is less than 5 centimeters
The lesion is not on joints.
Urban leishmaniasis (based on patient's clinical observations and regional epidemiology)
Exclusion criteria:
Pregnancy and breastfeeding
Existence of serious or severe underlying diseases (such as heart disease, kidney disease, liver disease, immunodeficiency)
Age
From 4 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
8
Randomization (investigator's opinion)
Not randomized
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
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.234
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
UIlcer development and complete lesion epithelialization in ulcerative lesions
Timepoint
Before, during and 12 weeks after the end of treatment
Method of measurement
Clinical observations
2
Description
Becoming flat and change in induration diameter in non-ulcerative lesions
Timepoint
Before, during and 12 weeks after the end of treatment
Method of measurement
Clinical observations
3
Description
Diameter of induration and erythema and ulcer size
Timepoint
Before, during and 12 weeks after the end of treatment
Method of measurement
Ruler and caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, methylene blue solution (50μL of 0.5% MB in water) is applied topically on the lesion (before prescribing methylene blue, if there is a crust in ulcerative lesions, it will be removed by curetting) and after 20 minutes of exposure to LED lamp (Red LED light, with 663 nm wavelength, 100mW / cm2) for 30 minutes, twice a week, for a maximum of 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Forough Rakhshanizadeh
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
rakhshanizadehf@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr. Forough Rakhshanizadeh
Street address
Ghaem hospital, Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91871 45785
Phone
+98 51 3840 0000
Email
rakhshanizadehf@mums.ac.ir
3
Recruitment center
Name of recruitment center
Ab-o Bargh Health Center
Full name of responsible person
Dr. Forough Rakhshanizadeh
Street address
Ab-o Bargh Health Center, Kuy-e-Ab-o-Barq
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3867 7606
Email
rakhshanizadehf@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@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
Forough Rakhshanizadeh
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Fax
Email
rakhshanizadehf@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Forough Rakhshanizadeh
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Fax
Email
rakhshanizadehf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Forough Rakhshanizadeh
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Fax
Email
rakhshanizadehf@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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Date can be accessible through an email to the corresponding author.
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutes,
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month.
What processes are involved for a request to access data/document