Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT05332093
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide informed consent
* Clinically confirmed CL diagnosis
* Between 12 and 50 years of age
Exclusion Criteria:
* Difficult or too painful sampling zone (see skin biopsy procedure below)
* (Primary) lesion size \< 1 cm
* Already receiving CL treatment or received CL treatment in the last 3 months (excluding traditional medicine)
* Known major comorbidity at time of diagnosis (e.g. VL, HIV, TB, malaria, severe intestinal helminth infection)
* Medical history of VL
* Severely underweight (BMI\<16)
* Known pregnancy
* Use of immunosuppressive medication in the last month
* Known excessive alcohol use (between \>10 intakes/day and \>10 intakes/week)
* History of hypersensitivity to local anaesthetics
* Presence of keloids/hypertrophic scars
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
50 Years
Study:
NCT05332093
Study Brief:
Protocol Section:
NCT05332093