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IRCT20200825048515N14 IRCT 2020-12-07 Esfahan University of Medical Sciences The effect of intralesional injection of glucantime with low-level laser therapy in the treatment of acute cutaneous leishmaniasis Comparing the effect of two therapeutical methods including intralesional injection of glucantime alone and with low-level laser therapy in the treatment of acute cutaneous leishmaniasis 2020-12-21 anticipated 54 Complete https://irct.ir/trial/52440 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 54 eligible patients will be simply randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. In this way, each of the generated codes will be assigned to a patient by chance, and therefore that patient will be studied in one of the two groups according to the code, Blinding description: Given that in this study both groups will be undergone glucantime injection and only one of these two groups will be treated with low-level laser therapy, so the patient and the care provider are aware of the type of intervention, but the researcher, results' evaluator, and data analyst will not have information of the two groups. N/A Acute cutaneous leishmaniasis. Intervention 1: Control group: Patients in the first group are treated only with intralesional injection of glucantime(Sanofi Company). The patient receives a topical injection of glucantime 0.5 to 1.5 cc per week per lesion; So that all around the lesion (one millimeter ring around it) becomes white. Topical treatment with injectable glucantime lasts up to 8 weeks. Intervention 2: Intervention group: Patients in the second group are also treated with an intralesional injection of glucantime. The patient receives a topical injection of glucantime 0.5 to 1.5 cc per week per lesion; So that all around the lesion (one-millimeter ring around it) becomes white. Topical treatment with injectable glucantime lasts up to 8 weeks. In addition, patients were treated by a low-level laser using an 820 nm probe 3 times a week for a total of 10 sessions at the intensity of 48 J/cm2 for 30 seconds and then at the intensity of 9.6 J/cm2 for 2 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Ali Asilian
Dermatology Department, Sedigheh Tahereh Clinic, Khoram Street, Isfahan.
Isfahan Iran (Islamic Republic of) 8139946111 +98 31 3335 9797 asilian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Ali Asilian
Dermatology Department, Sedigheh Tahereh Clinic, Khoram Street, Isfahan.
Isfahan Iran (Islamic Republic of) 8139946111 +98 31 3335 9797 asilian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Proven diagnosis of acute rural cutaneous leishmaniasis by testing The number of lesions of less than 4 The disease course of fewer than 100 days Lesion size of less than 3 cm No lesion on the eyelid (less than 2 cm from the eyelid) Aged over 5 years old No lesion on cartilage or joint and face 5 years no limit Both Presence of sporotrichoid lesions or satellite lesions Taking immunosuppressive drugs during the last 6 months The history of receiving topical or systemic anti-leishmaniasis treatment in the past month Lack of consent to participate in the study B55.1 Cutaneous leishmaniasis N/A Treatment - Other Control group: Patients in the first group are treated only with intralesional injection of glucantime(Sanofi Company). The patient receives a topical injection of glucantime 0.5 to 1.5 cc per week per lesion; So that all around the lesion (one millimeter ring around it) becomes white. Topical treatment with injectable glucantime lasts up to 8 weeks. Intervention group: Patients in the second group are also treated with an intralesional injection of glucantime. The patient receives a topical injection of glucantime 0.5 to 1.5 cc per week per lesion; So that all around the lesion (one-millimeter ring around it) becomes white. Topical treatment with injectable glucantime lasts up to 8 weeks. In addition, patients were treated by a low-level laser using an 820 nm probe 3 times a week for a total of 10 sessions at the intensity of 48 J/cm2 for 30 seconds and then at the intensity of 9.6 J/cm2 for 2 minutes Lesion healing. Timepoint: The first to twelfth weeks from the beginning of the intervention. Method of measurement: Observation. Lesion area. Timepoint: The first to twelfth weeks from the beginning of the intervention. Method of measurement: Ruler. Recurrence of the lesion. Timepoint: Three months and six months after the intervention. Method of measurement: Observation. Isfahan University of Medical Sciences Approved 2020-11-01 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)