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IRCT20190714044200N2 IRCT 2020-10-02 Shiraz University of Medical Sciences The effect of topical sodium chlorite gel in treatment of cutaneous leishmaniasis Comparison of the efficacy of topical sodium chlorite gel with intralesional injection of glucantime to cryotherapy with intralesional injection of glucantime for the improvement of lesions in patients with cutaneous leishmaniasis 2020-09-22 anticipated 48 Complete https://irct.ir/trial/51113 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Cutaneous leishmaniasis. Intervention 1: Intervention group: Topical treatment with sodium chlorite is done in such a way that 0.045% sodium chlorite gel is prepared by the hospital pharmacist and is given to patients in 200 gr containers and they are asked to use this drug daily at the wound site. And put a closed dressing on it. Repeat the next day after washing the wound with serum or with mild soap and water. Treatment with intralesional injection of glucantime according to the national guidelines for the treatment of cutaneous leishmaniasis with a fine needle number 27 or 30 at an angle of 45 degrees so that the tip of the needle is up and the center of the lesion, in the border of healthy skin and induction begins And 0.1 cc of the drug is injected into the dermis so that the margin of the lesion becomes white. This operation is repeated at intervals of 1 cm in the entire margin of the lesion and throughout the lesion. In large lesions and provided that the lesion center is not injured, 0.1 to 0.2 cc of drug is injected in the lesion center. This injection is given weekly until the end of the trial. The type of glucantime ampule used is the type imported by the Ministry of Health. Glucantime 1.5 gr / 5 CC is a product of the French company SANOFI. Intervention 2: Control group: In this group, treatment with intralesional injection of glucantime according to the national guidelines for the treatment of cutaneous leishmaniasis with a fine needle number 27 or 30 at an angle of 45 degrees so that the tip of the needle is up and the center of the lesion, in the border of healthy skin and induction begins And 0.1 cc of the drug is injected into the dermis so that the margin of the lesion becomes white. This operation is repeated at intervals of 1 cm in the entire margin of the lesion and throughout the lesion. In large lesions and provided that the lesion center is not injured, 0.1 to 0.2 cc of drug is injected in the lesion center. This injection is given weekly until the end of the trial. The type of glucantime ampule used is the type imported by the Ministry of Health. Glucantime 1.5 gr / 5 CC is a product of the French company SANOFI. Cryotherapy is done weekly by a dermatologist. The device manufactured by the company Iran Sarma darman is used and The chemical substance used in this method is a liquid nitrogen with temperature of -198. Each cryotherapy session is performed for two 20-second freezing cycles and a 60 second thawing cycle. Yes - There is a plan to make this available What will be shared: Information and data from the research: Information on the main outcome. When: Start the access period 6 months after printing the results. To whom: Researchers working in academic institutions. Conditions: Information on the main outcome in the form of correspondence with researchers. Where to obtain: Dermatology Department, Shiraz university of medical sciences. How to obtain: After applying to the office of the Department of Dermatology of Shiraz University of Medical Sciences, this request is sent to the university's vice chancellor. If the information is agreed upon, it is provided to the applicant. The approximate duration of this process is one week. Comments:
public Amir Miri
Department of Dermatology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3231 9049 miria@sums.ac.ir Shiraz University of Medical Sciences scientific Amir Miri
Zand Blvd, Shahid Faghihi Hospital, Dermatology Department office
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3231 9049 miria@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years of age with cutaneous leishmaniasis A maximum of 4 months have passed since the onset of cutaneous leishmaniasis in patients. 18 years no limit Both Immunodeficient individuals Cutaneous leishmaniasis on the face of patients Pregnancy and lactation Patients with more than 3 lesions of cutaneous leishmaniasis Patients with lesions greater than 5 cm in diameter Patients with concomitant mucosal lesions Patients who have received systemic or topical anti-leishmaniasis medication in the last 4 weeks. B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: Topical treatment with sodium chlorite is done in such a way that 0.045% sodium chlorite gel is prepared by the hospital pharmacist and is given to patients in 200 gr containers and they are asked to use this drug daily at the wound site. And put a closed dressing on it. Repeat the next day after washing the wound with serum or with mild soap and water. Treatment with intralesional injection of glucantime according to the national guidelines for the treatment of cutaneous leishmaniasis with a fine needle number 27 or 30 at an angle of 45 degrees so that the tip of the needle is up and the center of the lesion, in the border of healthy skin and induction begins And 0.1 cc of the drug is injected into the dermis so that the margin of the lesion becomes white. This operation is repeated at intervals of 1 cm in the entire margin of the lesion and throughout the lesion. In large lesions and provided that the lesion center is not injured, 0.1 to 0.2 cc of drug is injected in the lesion center. This injection is given weekly until the end of the trial. The type of glucantime ampule used is the type imported by the Ministry of Health. Glucantime 1.5 gr / 5 CC is a product of the French company SANOFI. Control group: In this group, treatment with intralesional injection of glucantime according to the national guidelines for the treatment of cutaneous leishmaniasis with a fine needle number 27 or 30 at an angle of 45 degrees so that the tip of the needle is up and the center of the lesion, in the border of healthy skin and induction begins And 0.1 cc of the drug is injected into the dermis so that the margin of the lesion becomes white. This operation is repeated at intervals of 1 cm in the entire margin of the lesion and throughout the lesion. In large lesions and provided that the lesion center is not injured, 0.1 to 0.2 cc of drug is injected in the lesion center. This injection is given weekly until the end of the trial. The type of glucantime ampule used is the type imported by the Ministry of Health. Glucantime 1.5 gr / 5 CC is a product of the French company SANOFI. Cryotherapy is done weekly by a dermatologist. The device manufactured by the company Iran Sarma darman is used and The chemical substance used in this method is a liquid nitrogen with temperature of -198. Each cryotherapy session is performed for two 20-second freezing cycles and a 60 second thawing cycle. Measuring the diameter of cutaneous leishmaniasis lesions in patients. Timepoint: At the beginning of the study, one week later, two weeks later, three weeks later, four weeks after starting treatment. Method of measurement: Measuring ruler. Shiraz University of Medical Sciences Approved 2018-10-15 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)