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IRCT20241028063523N3 IRCT 2024-11-25 Armed forces Hospital PNS Shifa Hospital Karachi, Pakistan Comparative efficacy of low dose oral dapsone and intralesional meglumine antimoniate with  intralesional meglumine antimoniate in patients presenting with cutaneous leishmaniasis. Comparative efficacy of low dose oral dapsone and intralesional meglumine antimoniate with  intralesional meglumine antimoniate in patients presenting with cutaneous leishmaniasis. 2024-11-21 anticipated 60 Complete https://irct.ir/trial/80285 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients presenting in the OPD of the Dermatology Department of PNS Shifa fulfilling the inclusion criteria will be included in this study. Written informed consent from the participants will be taken. Patients will be divided into two groups using lottery method. Demographic details which include age, weight, BMI, duration of disease, size , site and no. of lesions and gender will be noted and will be recorded on the approved performa. Group-A will receive intralesional meglumine antimoniate weekly and Group-B will receive oral dapsone (initially 25 mg/day for 01 week then 50mg/day onwards) with monitoring of Blood CP and Liver function tests and weekly intralesional meglumine antimoniate. Participants will be treated for 16 weeks or earlier if has occurred, whatever will be happened earlier. They will be evaluated in the 4th, 8th, 12th, 16th weeks of the treatment for efficacy. 4 Cutaneous leishmaniasis is caused by an “intracellular parasite” that is transferred to humans by a sand fly bite. It is endemic throughout Asia, Africa, Mediterranean region and America. It is estimated that there are between 0.7 to 1.2 million new cases of CL per year worldwide. It is a neglected third commonest vector borne disease in the world. It is widely spread in different parts of the world including South and Central America, Mediterranean Basin, Middle East and Central Asia.Leishmania tropicalis has a common association with the late ulcerative or dry urban type. The L. major causes the “wet, rural, or early” ulcerative type, which is characterized by many, eg’ often healing ulcers within a year. Mucocutaneous leishmaniasis, leishmaniasis recidivans, and diffuse cutaneous leishmaniasis are the rarest types of the disease .. Intervention group: Confirmed cases of cutaneous leishmaniasis will be divided into 02 groups .Group-A and Group-B. Group-A will receive intralesional meglumine antimoniate weekly and Group-B will receive oral dapsone (initially 25 mg/day for 01 week then 50mg/day onwards) with monitoring of Blood CP and Liver function tests and weekly intralesional meglumine antimoniate.. Yes - There is a plan to make this available What will be shared: APPENDIX 1: PROFORMA COMPARATIVE EFFICACY OF LOW DOSE ORAL DAPSONE AND INTRALESIONAL MEGLUMINE ANTIMONIATE WITH  INTRALESIONAL MEGLUMINE ANTIMONIATE IN PATIENTS PRESENTING WITH CUTANEOUS LEISHMANIASIS– A RANDOMIZED CONTROLLED TRIAL Name:   _______________________________              Age (years):  ___________________ Weight (kg): ____________________ BMI (kg/m2): __________________________              Duration (weeks) : _______________ Gender: Male/Female Size of lesion: Site of lesion: No. of lesion: Site: ·       Trunk ·       Arm ·       Hand ·       Leg ·       Feet Group: A ( I/L meglumine antimoniate weekly) Group : B ( Oral dapsone 50 mg/day and weekly I/L meglumine antimoniate) OUTCOME VARIABLE: EFFICACY: YES/NO When: After 6 months RCT , for 4 years To whom: Primary investigator Conditions: All patients in Dermatology OPD according to operational definition of cutaneous leishmaniasis fulling the inclusion criteria Where to obtain: Administration of PNS SHIFA HOSPITAL How to obtain: Contact to primary investigator Comments:
public Dr ATIYA RAHMAN
Sailor street, DHA PHASE II, PNS SHIFA HOSPITAL NEAR KALA PUL
Karachi Pakistan 07557 +92 21 48506540 jotyrani321@gmail.com Armed forces Hospital , PNS SHIFA scientific Dr Atiya Rahman
Sailor street , DHA phase II, PNS SHIFA HOSPITAL near Kala pul.
Karachi Pakistan 07557 +92 21 48506540 jotyrani321@gmail.com Armed forces Hospital PNS SHIFA Karachi , Pakistan Pakistan ·Patients between 16-60 years of age, patients with positive smear or skin biopsies for amastigotes, lesions four or less in number and no lesion more than 4cm in size.·       Either gender· Willing to provide informed consent. 16 years 60 years Both Pregnant or lactating women, sporotrichoid spread, use of any anti-leishmania treatment in the past 3 months, lesions at sites that merit systemic antimonials, allergy to antimonials and patients with history of liver disease,patient having G6PD deficiency will be  excluded from the study B55.1 Cutaneous leishmaniasis Treatment - Drugs Intervention group: Confirmed cases of cutaneous leishmaniasis will be divided into 02 groups .Group-A and Group-B. Group-A will receive intralesional meglumine antimoniate weekly and Group-B will receive oral dapsone (initially 25 mg/day for 01 week then 50mg/day onwards) with monitoring of Blood CP and Liver function tests and weekly intralesional meglumine antimoniate. Efficacy will be labeled if patients with CL lesion in either group showed complete response; complete re-epithelialization, disappearance of edema, induration, lesions becoming flatter and turning from erythematous to residual hyperpigmentation in colour assessed on photograph and clinical examination. Timepoint: Patient will be assessed before intervention and 4th ,8th , 12th , 16th weeks after intervention. Method of measurement: Patients having a typical, non-healing, painless, indurated papule, nodule, or plaque with or without crust on clinical assessment will labeled as having cutaneous leishmaniasis and will be confirmed by a direct smear taken from the lesions, which will then be stained with Giemsa stain showing Leishman bodies (amastigotes) on microscopic examination. , Skin biopsy to be done if required to confirm diagnosis. Side effects: Monitoring and documenting adverse effects related to the treatment, such as hemolysis, methemoglobinemia, peripheral neuropathy, allergic dermatitis, headache,. Timepoint: 4th, 8th, 12th, 16th weeks. Method of measurement: Patients having a typical, non-healing, painless, indurated papule, nodule, or plaque with or without crust on clinical assessment will labeled as having cutaneous leishmaniasis and will be confirmed by a direct smear taken from the lesions, which will then be stained with Giemsa stain showing Leishman bodies (amastigotes) on microscopic examination. , Skin biopsy to be done if required to confirm diagnosis. Armed forces Hospital PNS Shifa Hospital Karachi, Pakistan Approved 2024-11-18 Ethical committee PNS SHIFA PNS Shifa Hospital, Sailor street DHA phase ll , near Kala pul Karachi Sindh Pakistan