Study to determine the effectiveness, acceptability and feasibility of thermotherapy with radio frequency – induced heat therapy (RFHT) by ThermoMed device for the local/intra lesional treatment of cutaneous leishmaniasis in a selected routine clinic settings Sri Lanka.

Study to determine the effectiveness, acceptability and feasibility of thermotherapy with radio frequency – induced heat therapy (RFHT) by ThermoMed device for the local/intra lesional treatment of cutaneous leishmaniasis in selected routine clinic settings Sri Lanka.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2023/022

Enrollment

200

Registered

2023-12-01

Start date

2023-12-04

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis

Interventions

Study setting(s): TH Anuradhapura and DGH Hambantota Intervention: Thermotherapy by ThermoMedTM device will be given to patients as a single session of 50?C for 30 seconds on Day1. No other treatm

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients 2. Aged 18 years and above 3. Meeting the criteria for thermotherapy in accordance with the guidelines by the Sri Lanka College of Dermatologists: Inclusion criteria: 3.1 Papule, nodule or ulcer 3.2 Lesion on body or limbs 3.3 Diameter less than 4 cm 3.4 Number of lesions 1-4 lesions 3.5 Lesion on face or ear more than 2cm from lip/ eye or not located over cartilage.

Exclusion criteria

Exclusion criteria: 1.Lesion on face or ear closer than 2cm to lip/ eye or located over cartilage. 2.Diameter les more than 4cm 3.More than or equal to 5 lesions 4.Pregnant and lactating mothers (In accordance with the guidelines by the Sri Lanka College of Dermatologists) (

Design outcomes

Primary

Measure	Time frame
Initial cure: Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on Day 90 as compared to Day 1 and for non-ulcerated lesions as flattening and/or no signs of induration of the lesion(s) on Day 90 as compared to Day 1 [At Day 90, Day 105 and Day 180 after exposure to thermotherapy] Clinical improvement: Defined for ulcerated lesions as more than or equal to 75% but less than 100% re-epithelization of the ulcer(s) at Day 90 as compared to Day 1, and for nonulcerated lesions as more than or equal to 75% but less than 100% of flattening and/ or signs of induration of the lesion(s) at Day 90 as compared to Day 1 [ At Day 90, Day 105 and Day 180 after exposure to thermotherapy] Late responders: Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on Day 105 compared to Day 1, and for non-ulcerated lesions as 100% of flattening and/or no signs of induration of the lesion(s) on Day 105 as compared to Day 1 [ At Day 90, Day 105 and Day 180 after exposure to thermotherapy] Final cure: Initial cure at Day 90 or late responders at Day 105 (if required) and no relapses by Day 180. Relapse: Lesion that achieved 100% re-epithelialization/flattening on Day 90 or Day 105 (if required) that subsequently reopened /indurated by Day 180. [ At Day 90, Day 105 and Day 180 after exposure to thermotherapy]	—

Measure

Time frame

Initial cure: Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on Day 90 as compared to Day 1 and for non-ulcerated lesions as flattening and/or no signs of induration of the lesion(s) on Day 90 as compared to Day 1 [At Day 90, Day 105 and Day 180 after exposure to thermotherapy] Clinical improvement: Defined for ulcerated lesions as more than or equal to 75% but less than 100% re-epithelization of the ulcer(s) at Day 90 as compared to Day 1, and for nonulcerated lesions as more than or equal to 75% but less than 100% of flattening and/ or signs of induration of the lesion(s) at Day 90 as compared to Day 1 [ At Day 90, Day 105 and Day 180 after exposure to thermotherapy] Late responders: Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on Day 105 compared to Day 1, and for non-ulcerated lesions as 100% of flattening and/or no signs of induration of the lesion(s) on Day 105 as compared to Day 1 [ At Day 90, Day 105 and Day 180 after exposure to thermotherapy] Final cure: Initial cure at Day 90 or late responders at Day 105 (if required) and no relapses by Day 180. Relapse: Lesion that achieved 100% re-epithelialization/flattening on Day 90 or Day 105 (if required) that subsequently reopened /indurated by Day 180. [ At Day 90, Day 105 and Day 180 after exposure to thermotherapy]

—

Secondary

Measure	Time frame
Acceptability and feasibility will be assessed as per the Focused Group Discussions guide. FGDs will be conducted by a sociologist. [FGDs will be conducted by a sociologist on the 105th Day (+/- 10 days) follow up visit post-exposure.]	—

Countries

Sri Lanka

Contacts

Public ContactNadira D. Karunaweera

Professor

nadira@parasit.cmb.ac.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026