]>
IRCT20200803048289N1 IRCT 2020-08-31 Mashhad University of Medical Sciences The effect of of photodynamic therapy with methylene blue on the treatment of cutaneous leishmaniosis Investigation of the effect of of photodynamic therapy with methylene blue on the treatment of cutaneous leishmaniosis 2020-05-04 anticipated 8 Complete https://irct.ir/trial/50557 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Cutaneous leishmaniasis. 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.. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Date can be accessible through an email to the corresponding author. Conditions: Data will be available for researchers in universities and other scientific institutes, Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Forough Rakhshanizadeh
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2406 rakhshanizadehf@mums.ac.ir Mashhad University of Medical Sciences scientific Forough Rakhshanizadeh
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2406 rakhshanizadehf@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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) 4 years 65 years Both Pregnancy and breastfeeding Existence of serious or severe underlying diseases (such as heart disease, kidney disease, liver disease, immunodeficiency) B55.1 Cutaneous leishmaniasis Treatment - Drugs 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. 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. 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. 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. Mashhad University of Medical Sciences Approved 2020-04-29 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhhad Razavi Khorasan Iran (Islamic Republic of)