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IRCT138904241475N5 IRCT 2015-09-21 The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO) Double blind, randomized clinical trial on efficacy of combination of Glucantime and topical paromomycin for the treatment of cutaneous leishmaniasis caused by Leishmania tropica Double blind, randomized clinical trial on efficacy of combination of meglumine antimoniate (Glucantime) and topical nano-liposomal paromomycin for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica 2011-04-04 anticipated 120 Complete https://irct.ir/trial/749 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Protozoal diseases. Intervention 1: Control:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical placebo twice daily for 28 days. Intervention 2: Intervention:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical Lip-PM twice a day for 28 days.
public Ali Khamesipour
Center for Research and Training in Skin Diseases and Leprosy, P.O.Box 14155-6383
Tehran Iran (Islamic Republic of) 14155-6383 +98 21 8897 0657 Khamesipour_ali@yahoo.com Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences scientific Ali Khamesipour
Center for Research and Training in Skin Diseases and Leprosy, P.O.Box 14155-6383
Tehran Iran (Islamic Republic of) 14155-6383 +98 21 8897 0657 Khamesipour_ali@yahoo.com Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences Iran (Islamic Republic of) I) Inclusion criteria:a) Parasitologically proven cases* of CL based on positive smear and/or culture; b) Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician); c) Age 12-60 years; d) Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years). * Direct smear, culture and PCR will be done on every sample to identify the causative agent. II) Exclusion criteria: a) Pregnant or lactating women; b) Duration of lesion more than 6 months; c) Number of lesions more than 4; d) Ulcer size greater than 3 cm in their largest diameter; e) History of full course of standard treatment (antimonials); f) History of allergy to Glucantime; g) Serious systemic illnesses (as judged by the physician); h) Participation in any drug trials in the last 60 days. 12 years 60 years Both B55.1 Cutaneous leishmaniasis Placebo Treatment - Drugs Control:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical placebo twice daily for 28 days Intervention:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical Lip-PM twice a day for 28 days Complete re-epithelization of all lesions with disappearance of induration. Timepoint: weekly. Method of measurement: Digital pictures. Reduction in the size of ulcer and induration. Timepoint: weekly. Method of measurement: Digital pictures. The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO) Approved 2010-07-31 National Ethical Committee on Biomedical Research Ministry of Health Tehran Iran (Islamic Republic of)