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IRCT20081130001475N13 IRCT 2019-12-30 Tehran University of Medical Sciences Randomized trial of local injections for cutaneousleishmaniasis caused by L. tropica Efficacy of intra-lesional injections of meglumine antimoniate once a week vs. twice a week in the treatment of cutaneous leishmaniasis caused by L. tropica in Iran 2017-09-23 anticipated 180 Complete https://irct.ir/trial/44450 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sequence was generatedusing version 16 of SPSS (SPSS Inc. Chicago, IL, USA) software. To conceal the random sequence from the recruiter, sequentially-numbered opaque sealed envelope (SNOSE) was used. 3 Leishmania. Intervention 1: Intervention group: Once injection per week. Intervention 2: Intervention group: Twice a week. Yes - There is a plan to make this available What will be shared: Lesion measurement and drug side effects When: Since 1398 To whom: Reseacher Conditions: Reseacher Where to obtain: Ali Khamesipour How to obtain: Visit the center and provide reasons for their use Comments:
public Ali Khamesipour
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2221 ali.khamesipour@gmail.com Tehran University of Medical Sciences scientific Ali Khamesipour
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2221 ali.khamesipour@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 80-70 year old patients with clinically suspected CL lesion(s) with Parasitological proven (smear and/or culture) CL patients caused by L. tropica were recruited into the study if they met other eligibility criteria. Polymers chain reaction (PCR) was performed on every sample to assure that the lesion was caused by L. tropica. Other inclusion criteria were age 8-70 years, willingness to participate in the trial, and sign an informed consent and an oral assent from the children. 8 years 70 years Both Patients with lesion(s) duration more than 6 months, more than 4 lesions, ulcer size more than 3 cm, lesions on the face or close to a vital organ, pregnant and nursing patients, those with a history of previous systemic or IL treatment with MA or those with an acute or chronic disease that could affect the course of CL or treatment with IL-MA injections were excluded. B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: Once injection per week Intervention group: Twice a week Primary outcome of the study was complete cure defined as complete re-epithelialization of the lesion with no induration. Timepoint: Before the intervention and every week. Method of measurement: Measurement of the lesion. Tehran University of Medical Sciences Approved 2013-06-23 کمیته اخلاق دانشگاه، مركز آموزش و پژوهش بیماریهای پوست و جذام، دانشگاه علوم پزشکی تهران 415 Taleghani Avenue Tehran Tehran Iran (Islamic Republic of)