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IRCT20140211016554N4 IRCT 2019-04-28 Mashhad University of Medical Sciences Evaluation of the effectiveness of oral dapsone with intralesional antimoniate in treatment of cutaneous leishmaniasis Evaluation of the effectiveness of oral dapsone with intralesional antimoniate in treatment of cutaneous leishmaniasis in comparison with intralesional antimoniate alone 2013-01-20 anticipated 100 Complete https://irct.ir/trial/15463 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization will be carried out using table of random numbers produced by a computer. 2-3 Cutaneous Leishmaniasis. Intervention 1: In control group, patients receive intralesional glucantime injection weekly for 4-8 weeks. Intervention 2: In intervention group, weekly intralesional injection of glucantime starts for 6 weeks in addition to 1 mg/kg of oral dapsone daily and in the case that primary control tests are normal, dapson dosage will increase to 2 mg/kg. 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: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Azadeh Mohammadi
Ghaem Hospital, Ahmad Abad Street
Mashhad Iran (Islamic Republic of) 9176699199 +98 51384012493 src@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Vahid Mashayekhi-Goyonlo
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2020 mashayekhiv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) positive direct smear of the lesion in terms of leishman bodies patient has indication of topical treatment according to the physician less than six month has elapsed since the manifestation of lesion patient has not received any previous treatment for cutaneous leishmaniasis intervention group has normal values for CBC;G6PD;LFT location of lesion is either on upper limbs or face 10 years 40 years Both sensitivity to glucantime (severe topical reaction, anaphylaxis). absence of regular follow-ups existence of secondary infection in lesion use of other treatments during the study dapsone side effects including methemoglobinemia, hemolytic anemia, agranulocytosis, peripheral neuropathy, hypersensitivity B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs In control group, patients receive intralesional glucantime injection weekly for 4-8 weeks. In intervention group, weekly intralesional injection of glucantime starts for 6 weeks in addition to 1 mg/kg of oral dapsone daily and in the case that primary control tests are normal, dapson dosage will increase to 2 mg/kg. Change in size of the lesion. Timepoint: At the end of each week. Method of measurement: based on lesion induration measured by a caliper. Side effects. Timepoint: weekly. Method of measurement: clinical evaluation. Mashhad University of Medical Sciences Approved 2010-09-23 Ethics committee of Mashhad University of Medical Sciences central building of Mashhad University of Medical Sciences(Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)