Cutaneous leishmaniasis
Conditions
Interventions
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 g
Sponsors
University Of Colombo, Sri Lanka
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of initial cure rate in each treatment arm (defined as: Reduction of lesion size at least by 50% of the pre-treatment size) [Day 90 from the commencement of the interventions] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) [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 ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Hermali Silva
Lecturer, Department of Parasitology, Faculty of Medicine, University of Colombo, Sri Lanka.
Outcome results
None listed