Study to compare thermotherapy and intralesional drug injection for the treatment of patients with cutaneous leishmaniasis lesions in Syria.

Phase 4

• Conditions: Cutaneous Leishmaniasis; Skin - Other skin conditions; Infection - Other infectious diseases

• Registration Number: ACTRN12621000831886
• Lead Sponsor: The MENTOR Initiative

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-29
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

All patients who present to the 5 selected static health facilities and mobile treatment clinics with Cutaneous Leishmaniasis lesions will be eligible for inclusion in this study if they meet all of the inclusion criteria and none of the exclusion criteria.

The inclusion criteria are as follows:
1. Participant with clinically diagnosed Old World Cutaneous Leishmaniasis < 4 cm in size
2. Participant is willing and able to give informed consent for participation in the study or
3. For children at least 5 years, a parent or guardian gives informed consent on their behalf
4. Participant agrees to follow the study processes and attend the follow-up appointment 3 months post treatment completion

Exclusion Criteria

1. Pregnancy by history
2. Lactation
3. Lesions
*on or directly adjacent to lips, eyes/eyelids, nose
*nose
*ear
*fingers/toes
*close to carotid and jugular vessels in neck
*antecubital fossa region
*on volar aspect of wrist joint
4. Implantable cardiac devices such as pacemakers
5. Metallic implants such as metal plates in skull
6. Previous history of treatment to same lesion(s)

Study & Design

• Study Type: Interventional
• Study Design: Not specified