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IRCT20220529055013N2 IRCT 2024-02-02 TDR/EMRO /WHO Comparative Assessment of Standard of Care Intralesional Therapy Versus Combination of Thermal Therapy with Standard of care intralesional Therapy for skin lesions in Cutaneous Leishmaniasis in Pakistan Comparative Assessment of Sodium Stibogluconate/Meglumine Intralesional Therapy Versus Combination of Thermal Therapy with Sodium Stibogluconate/Meglumine intralesional Therapy for skin lesions in Cutaneous Leishmaniasis in Pakistan 2024-02-01 anticipated 132 Complete https://irct.ir/trial/74911 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with Cutaneous Leishmaniasis presenting to clinical practice will be invited to participate in the study, after being diagnosed by microscopy. All the patients fulfilling the inclusion/exclusion criteria will be formally consented by data collector for participating in the study. Patients who will voluntarily agree to participate and comply with study protocol will be randomized to either treatment or control group by data collector. Stratified block randomization method will be used in this study, with patients stratified for number/size of skin lesion (mild to moderate/ severe disease) and age. Only those participants/guardian/parents of participants who will voluntarily consent to participate in the study will be enrolled. In following circumstances, the subjects may be withdrawn from the study prior the expected completion: • Failure of subject to adhere to the protocol requirements • Subject consent withdrawal Randomization sequences will be generated and secured in opaque envelopes and will be kept in lock & key in separate room which will be only opened at the time of consent taking and randomization. 2-3 Cutaneous Leishmaniasis. Intervention 1: Treatment group: In this group, the skin lesion of patient along with 2 cm border of healthy skin around the lesion will be disinfected with antiseptic, followed by administration of local anesthesia with lignocaine. The skin lesion will then be exposed to thermal therapy((ThermoMed Model 1.8, Chemosurgery Inc. Phoenix-USA), to heat the affected area of the skin. The target temperature of 50°C willl be maintained for 30 seconds until whole lesion is covered. The area between the electrodes covers 49–73 mm2, therefore, several thermotherapy applications will be given to cover the whole lesion. From second visit onwards, the patients belonging to intervention group will be administered intralesional Meglumine (1.5gm/5ml equivalent to 81mg of antimony per 01 ml) 1-5ml mixed with 1:1 1% lidocaine, depending on lesion size but not exceeding 5 ml of total in one session. Intervention 2: Control group: Meglumine intralesional injection will be given as first treatment session, followed by weekly sessions. Treatment sessions will be repeated on a weekly basis in the same manner for both the groups, where 4-6 sessions will be provided depending on the treatment response. Treatment responses will be assessed in both groups weekly until the treatment ends (maximum of 5 sessions) and follow-up visits at 8th week and 12th week post-treatment will be completed. Acute adverse reactions, adverse events and post-treatment adverse events will also recorded for both the groups. Yes - There is a plan to make this available What will be shared: Results from the study in the form of tables and graphs of primary and secondary will be shared When: The data will be kept for 2 years. The results and findings of the study will be available in the form of publication. The data details can be shared with the journal on demand. To whom: Principal Investigator and co-investigator Conditions: The data document can be shared with the publishing journal on demand Where to obtain: Can contact the principal investigator. How to obtain: Principal investigator can be accessed through email. dr.nafisa.tahir@gmail.com Comments:
public Nafisa Tahir
Abid Majeed Road Rawalpindi
Islamabad Pakistan 44000 +92 51 9270175 dr.nafisa.tahir@gmail.com National University of Medical Sciences scientific Saleem Ahmed Khan
Abid Majeed Road
Islamabad Pakistan 44000 +92 51 9270677 Director.RC@numpspak.edu.pk National University of Medical Sciences Pakistan Diagnosis of cutaneous leishmaniasis by direct examination under microscopy voluntarily agreeing to participate in the study and complying with study follow-up visits will be considered for enrollment. 2 years 80 years Both • Other forms of Leishmaniasis i.e., mucocutaneous and/or visceral leishmaniasis (clinical exclusion) Patients already receiving treatment for Cutaneous Leishmaniasis• Known hypersensitivity to stibogluconate/meglumine antimoniate Pregnancy/lactation Comorbidities or other illness which may hinder the completion and follow-up of study B55.1 Cutaneous leishmaniasis Treatment - Devices N/A Treatment group: In this group, the skin lesion of patient along with 2 cm border of healthy skin around the lesion will be disinfected with antiseptic, followed by administration of local anesthesia with lignocaine. The skin lesion will then be exposed to thermal therapy((ThermoMed Model 1.8, Chemosurgery Inc. Phoenix-USA), to heat the affected area of the skin. The target temperature of 50°C willl be maintained for 30 seconds until whole lesion is covered. The area between the electrodes covers 49–73 mm2, therefore, several thermotherapy applications will be given to cover the whole lesion. From second visit onwards, the patients belonging to intervention group will be administered intralesional Meglumine (1.5gm/5ml equivalent to 81mg of antimony per 01 ml) 1-5ml mixed with 1:1 1% lidocaine, depending on lesion size but not exceeding 5 ml of total in one session. Control group: Meglumine intralesional injection will be given as first treatment session, followed by weekly sessions. Treatment sessions will be repeated on a weekly basis in the same manner for both the groups, where 4-6 sessions will be provided depending on the treatment response. Treatment responses will be assessed in both groups weekly until the treatment ends (maximum of 5 sessions) and follow-up visits at 8th week and 12th week post-treatment will be completed. Acute adverse reactions, adverse events and post-treatment adverse events will also recorded for both the groups. 1. Assessment of treatment efficacy in terms of treatment response among both study groups, assessed after 4-6 therapy sessions. Timepoint: Week 0, week 4, Week 8, Week 12. Method of measurement: Treatment Response labelled as: Complete response (complete re-epithelialization, disappearance of edema, induration, and other signs of inflammation), Partial response (decrease in lesion size not more than 50%, without appearance of epidermal crease)• Failure to response (no re-epithelialization). Safety adverse effects. Timepoint: 0week, 4 weeks, 8 weeks, 12 weeks. Method of measurement: Assessment of treatment safety in terms of occurrence of known/unknown device and drug reactions/side effects at each follow-up visit. Safety assessment is defined as:• Local side effects o Redness, Itching, Burning, Blister formation, Oozing. TDR/EMRO /WHO Approved 2021-12-24 National Bioethics Committee Health Research Institute, Shahrah-e-Jamhuriat, Off Constitution Avenue, Sector G-5/2, Islamabad Islamabad Capital Territory Pakistan