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Efficacy and safety of thermotherapy by Hand-held Exothermic Crystallization Thermotherapy device compared to ThermoMed device, for treatment of cutaneous leishmaniasis showing poor response to intralesional sodium stibogluconate in Sri Lanka - A randomized controlled pilot study -

SLCTR Registration Number

SLCTR/2016/025


Date of Registration

13 Oct 2016

The date of last modification

Jan 03, 2017



Application Summary


Scientific Title of Trial

Efficacy and safety of thermotherapy by Hand-held Exothermic Crystallization Thermotherapy device compared to ThermoMed device, for treatment of cutaneous leishmaniasis showing poor response to intralesional sodium stibogluconate in Sri Lanka - A randomized controlled pilot study


Public Title of Trial

Study of the effect of heat for treatment of cutaneous leishmaniasis showing poor response to intralesional sodium stibogluconate in Sri Lanka, by two devices (Hand-held Exothermic Crystallization Thermotherapy device versus ThermoMed device).


Disease of Health Condition(s) Studied

Cutaneous leishmaniasis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1187-5835


Any other number(s) assigned to the trial and issuing authority

(1) EC/16/077 - Ethics Review Committee, Faculty of Medicine, University of Colombo, Sri Lanka. (2) NMRA/CT/07/2016: National Medicines Regulatory Authority


Trial Details


What is the research question being addressed?

Is thermotherapy by the hand-held Exothermic Crystallization (HECT) device equally safe and effective when compared to thermotherapy by the ThermoMed device (localized radiofrequency induced heat device), in the treatment of cutaneous leishmaniasis showing poor response to intralesional sodium stibogluconate?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Treatment


Purpose


Intervention(s) planned

Study setting: Skin clinics of selected hospitals in Sri Lanka.

Method of allocation: Patients who are enrolled to the study will be allocated to two arms using block randomization with a computer generated random number series with block sizes 4 and 6.

Arm 1 will receive Thermotherapy by hand-held Exothermic Crystallization (HECT), one application daily at 51oC for 3 minutes duration given for 7 consecutive days.

Arm 2 will receive Thermotherapy by ThermoMed device, as a single application at 50oC for a duration of 30 seconds.


Inclusion criteria

  1. Age more than 12 years and less than 65 years
  2. Parasitologically confirmed CL lesion
  3. Undergone at least 10 intralesional injections of sodium stibogluconate
  4. Form of lesion: localized nodules, papules, ulcerating nodules, ulcers or plaques and the number of lesions: one.
  5. Longest diameter of the lesion less than 5cm

Exclusion criteria

  1. Any known chronic or concomitant illness such as hypertension, diabetes, heart disease, chronic renal or liver disease as determined by the investigators.
  2. Pregnancy
  3. Breastfeeding
  4. Immuno-compromised status including HIV co-infection and patients on immune-suppressants.
  5. Patients with more than one CL lesion
  6. Lesions which are on the nose or cartilaginous part of the ear or very close to the eyes and lips or which are situated lesser than 2cm away from a mucous membrane.
  7. Incapability of participant or the guarding to comply with the protocol as judged by the investigator.
  8. Anticipated unavailability for follow up visits
  9. Persons on pacemakers or having any implanted metallic devices
  10. Lesions which are infected


Primary outcome(s)

Proportion of initial cure rate in each treatment arm (defined as: Reduction of lesion size at least by 50% of the pre-treatment size)


Primary outcome(s) - Time of assessment(s)

Day 90 from the commencement of the interventions


Secondary outcome

  1. Presence or absence of adverse effects in each treatment group. (i) Pain (using Wong-Baker visual analogue scale) (ii) Blisters, scarring and secondary infection (clinical observation)

  2. Proportion of lesions (papules/nodules/plaques) with 100% reduction in size compared with the pre-treatment size at each measurement time point (at each follow up visit)

  3. Proportion of patients with 100% reduction in size compared with the pre-treatment size of the ulcerated lesions over time

  4. Proportion who has achieved final cure (no lesional relapse by day 180)


Secondary outcome(s) - Time of assessment(s)

Outcomes 1-3: At follow up visits on day 14,30,60,90,180 from the commencement of the intervention

Outcome 4: At the follow-up visit on day 180 from the commencement of the intervention



Target number/sample size

40 (20 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-10-17


Anticipated end date

2017-10-17


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Colombo on 21st July 2016 (Ref: EC-16-077)


Funding source

University of Colombo Small Research Grant (No: AP/3/2/2016/SG/13)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Hermali Silva
Lecturer, Department of Parasitology, Faculty of Medicine, University of Colombo, Sri Lanka.
Department of Parasitology, Faculty of Medicine, University of Colombo, No.25, Po Box. 271, Kynsey Road,Colombo - 08, Sri Lanka.

Mob: 0772621361

hermalisilva@gmail.com

Contact Person for Public Queries

Prof. Nadira Karunaweera
Professor, Department of Parasitology, Faculty of Medicine, University of Colombo, Sri Lanka.
Department of Parasitology, Faculty of Medicine, University of Colombo, No.25, Po Box. 271, Kynsey Road,Colombo - 08, Sri Lanka.
Tel: 011-2699284


nadira@parasit.cmb.ac.lk


Primary study sponsor/organization

University Of Colombo, Sri Lanka

College House, University of Colombo No 94, Cumaratunga Munidasa Mw, Colombo 03
Tel: (+94) 112 581 835


www.cmb.ac.lk

Secondary study sponsor (If any)

None