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IRCT20171230038142N17 IRCT 2020-03-27 Esfahan University of Medical Sciences Comparison of the effect of liposomal clarithromycin plus glucantime and glucantime in treatment of cutaneous leishmaniasis Comparison of the effect of liposomal clarithromycin plus glucantime and glucantime in treatment of cutaneous leishmaniasis 2019-12-22 anticipated 60 Complete https://irct.ir/trial/46611 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with leishmania at the Isfahan Leishmania Center who meet the inclusion criteria are selected easily and readily. Then, as long as 60 samples are prepared, sampling continues. Each person with 5 wounds is considered as a block and one intervention (liposomal with glucantime or glucocantime with placebo) is performed. Therefore, there are 6 people in each group. These individuals are divided into control and intervention groups using spss computer program. Subsequently, patients were divided into two groups of 30 patients receiving liposomal clarithromycin with glucantime and glucantime with placebo, Blinding description: Patients in each group are not aware of the therapeutic content of the other group. Data is also provided to the data analyzer after anonymization. 2-3 leishmaniasis. Intervention 1: Control group: Patients with leishmania are treated with glucantime and placebo for 28 days and three times daily. To prescribe this medicine, the patient is first fully instructed and a complete explanation of how the drug is practiced is given to the patient. The patient is given three phalluses, the first one being six weeks after the second treatment, three months later, and the third six months later. Patients were evaluated three times, first by clinical examination and re-epithelization, and then by the size of the lesions before and after treatment. Intervention 2: Intervention group: For the 30 randomized patients in the intervention group in addition to glucantime, liposomal formulations of topical clarithromycin are provided by dehydration-release. For this purpose, dipalmitoyl phosphatidylcholine (DPPC) and cholesterol in molar ratio of 6 to 1 are used. 114 mg of DPPC and 10 mg of cholesterol are added to a round bottom balloon and dissolved in sufficient chloroform-methanol (2: 1 ratio). The solubility in the rotor is dried and transformed into a thin film. Then 1 mg of clarithromycin is dissolved in 1 ml of phosphate buffer at pH 7.4 and then used to hydrate the lipid film. The resulting suspension is vortexed for 5 minutes and then subjected to ultrasound in a 45 Hz ultrasonic bath for 2 minutes. The resulting suspension is frozen and stored in the refrigerator when used. To prescribe medication, the patient is first fully instructed and a complete explanation of how the drug is practiced is given to the patient. The patient uses liposomal clarithromycin every night. The duration of treatment is 28 days. The patient is given three phalluses, the first one being six weeks after the second treatment, three months later, and the third one 6 months later. Patients were evaluated three times, first through clinical examination and re-epithelization and then the size of the lesions that were photographed before and after treatment. Yes - There is a plan to make this available What will be shared: The information is shared two years after the results are published. When: The information is shared two years after the results are published. To whom: Specialists and assistants in the infectious and dermatology department Conditions: Compare this medicine with another medicine Where to obtain: Send mehrradreza1@Yahoo.Com an email How to obtain: Send mehrradreza1@Yahoo.Com an email Comments:
public Reza Radmehr
Isfahan University of Medical Sciences, Hazar Jarib Street
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8597 mehrradreza1@Yahoo.Com Esfahan University of Medical Sciences scientific Atusa Hakami Fafd
Al-Zahra Hospital, Sofah Boulevard.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 a.hakamifard@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Ages 15 to 65 years Skin lesion with a diameter greater than 5 cm Cartilage or articular or facial lesion Number of lesions over 5 in patient Leishmania's disease has been proven by the patient's Smear For Leishman Body Test. 15 years 65 years Both Pregnant or lactating patients. History of concurrent or previous treatment for the lesion. Have heart, kidney, liver problems, drug side effects. The patient's unwillingness. B55 Leishmaniasis Placebo Treatment - Drugs Control group: Patients with leishmania are treated with glucantime and placebo for 28 days and three times daily. To prescribe this medicine, the patient is first fully instructed and a complete explanation of how the drug is practiced is given to the patient. The patient is given three phalluses, the first one being six weeks after the second treatment, three months later, and the third six months later. Patients were evaluated three times, first by clinical examination and re-epithelization, and then by the size of the lesions before and after treatment. Intervention group: For the 30 randomized patients in the intervention group in addition to glucantime, liposomal formulations of topical clarithromycin are provided by dehydration-release. For this purpose, dipalmitoyl phosphatidylcholine (DPPC) and cholesterol in molar ratio of 6 to 1 are used. 114 mg of DPPC and 10 mg of cholesterol are added to a round bottom balloon and dissolved in sufficient chloroform-methanol (2: 1 ratio). The solubility in the rotor is dried and transformed into a thin film. Then 1 mg of clarithromycin is dissolved in 1 ml of phosphate buffer at pH 7.4 and then used to hydrate the lipid film. The resulting suspension is vortexed for 5 minutes and then subjected to ultrasound in a 45 Hz ultrasonic bath for 2 minutes. The resulting suspension is frozen and stored in the refrigerator when used. To prescribe medication, the patient is first fully instructed and a complete explanation of how the drug is practiced is given to the patient. The patient uses liposomal clarithromycin every night. The duration of treatment is 28 days. The patient is given three phalluses, the first one being six weeks after the second treatment, three months later, and the third one 6 months later. Patients were evaluated three times, first through clinical examination and re-epithelization and then the size of the lesions that were photographed before and after treatment. The size of the lesion. Timepoint: Before, 6 weeks, 12 weeks and 6 months after intervention. Method of measurement: Physical examination. Frequency of waste. Timepoint: Before, 6 weeks, 12 weeks and 6 months after intervention. Method of measurement: Physical examination. Drug side effects. Timepoint: 6 weeks, 12 weeks and 6 months after intervention. Method of measurement: Physical examination. Esfahan University of Medical Sciences Approved 2019-10-15 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan Isfehan Iran (Islamic Republic of)