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IRCT20180411039265N1 IRCT 2018-05-05 Mashhad University of Medical Sciences Comparison of the effect of oral clarithromycin with systemic glucantime on the treatment of acute cutaneous leishmaniasis A comparative study of the effect of oral clarithromycin with systemic glucantime on the treatment of acute cutaneous leishmaniasis 2016-11-02 anticipated 20 Complete https://irct.ir/trial/30698 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method is used to divide the patients into intervention and control groups. 1 Cutaneous Leishmaniasis. Intervention 1: Intervention group: reception of oral Clarithromycin with 500 mg dosage twice a day for two months. Intervention 2: Control group: treatment with systemic glucantime with 20 mg/kg dosage per day for 20 days up to 3 ampules daily. 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 Somaye Ghanizadeh
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 5733 somayeghanizadeh@gmail.com Mashhad University of Medical Sciences scientific Naghmeh Zabolinejad
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 5733 zabolinejadng@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) having an indication of systemic treatment in patients with acute cutaneous leishmaniasis less than 12 weeks of illness receiving no previous treatment 16 years no limit Both Pregnancy Breastfeeding Use of other methods of treatment during the course of treatment Past medical history of any local or systemic disease during the last 2 months History of intolerance or allergies to macrolides A significant underlying disease such as heart, renal, or liver diseases. Use of other treatments before referral B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: reception of oral Clarithromycin with 500 mg dosage twice a day for two months Control group: treatment with systemic glucantime with 20 mg/kg dosage per day for 20 days up to 3 ampules daily Percentage of complete recovery of the lesion. Timepoint: Follow-up and assessment of recovery are done every two weeks, and the duration of the therapeutic effect of the lesions is assessed based on changes in the size, extent, redness and firmness of the lesions. The treatment period is considered two month. Patients will also be followed 6 weeks, 3 months and 6 months after the treatment is over. Method of measurement: Measuring size of the lesion with digital caliper. Mashhad University of Medical Sciences Approved 2016-10-05 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)