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.
Phase 4
Recruiting
- Conditions
- Cutaneous Leishmaniasis
- Registration Number
- SLCTR/2023/022
- Lead Sponsor
- Faculty of Medicine, University of Colombo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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:
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
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)
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method