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IRCT20140414017271N6 IRCT 2019-02-17 Mashhad University of Medical Sciences Investigation of the effect of diphencypron on treatment of acute urban leishmaniasis with intralesional injection of glucantime Investigation of the therapeutic effect of diphencyprone induced local hypersensitivity on treatment of acute urban leishmaniasis with intralesional injection of glucantime 2017-11-01 anticipated 44 Complete https://irct.ir/trial/33785 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done through the random allocation list by PASS software. 2-3 Cutaneous leishmaniasis. Intervention 1: Intervention group: At the same time as intralesional injection of glucantime, after sensitization with 2% diphencyprone (produced by the American corporation Sigma)solution on the upper arm, increasing doses of diphencyprone will be used weekly up to the development of eczema (erythema and itching for at least 2 days) and weakly treatment will continue until complete recovery with a sensitization dose. Intervention 2: Control group: Patients undergoing intralesional injection of glucantime (produced by the French corporation Sanofi) will continue treatment weekly until complete recovery. 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: Data analysis 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 Faeze Taghavi
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 5732 taghavif941@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Yalda Nahidi
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 5732 nahidiy@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Positive smear or biopsy of the lesion in terms of Leishman body Lesion in limbs dry leishmaniasis The patient has an indication of topical treatment based on the judgment of the therapist and the national protocol for leishmania A maximum of 6 months has elapsed since the onset of the lesion The patient has an informed consent to participate in the study. no limit no limit Both Sensitivity to intralesional injection of glucantime The presence of secondary infection in the lesion based on the researcher's judgment Pregnancy or breastfeeding Wet leishmaniasis, Lupoid, Sporotricoid B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: At the same time as intralesional injection of glucantime, after sensitization with 2% diphencyprone (produced by the American corporation Sigma)solution on the upper arm, increasing doses of diphencyprone will be used weekly up to the development of eczema (erythema and itching for at least 2 days) and weakly treatment will continue until complete recovery with a sensitization dose. Control group: Patients undergoing intralesional injection of glucantime (produced by the French corporation Sanofi) will continue treatment weekly until complete recovery. The rate of recovery in the two groups. Timepoint: Every week after the injection up to 12 weeks. Method of measurement: Size of the lesions will be recorded using a ruler and stiffness and induration will also be recorded based on examination in each session. The amount of time needed for the lesions to heal. Timepoint: Every week until lesion recovery. Method of measurement: Based on the number of weeks passed until recovery. Mashhad University of Medical Sciences Approved 2017-02-08 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)