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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT00351520
Eligibility Criteria:
Inclusion Criteria:
* Parasitologically proven cases of CL based on positive smear and/or culture
* Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)
* Age 12-60 years
* Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).
Exclusion Criteria:
* Pregnant or lactating women
* Duration of lesion more than 6 months
* Number of lesions more than 4
* Ulcer size greater than 4 cm in their largest diameter
* History of full course of standard treatment (antimonials)
* History of allergy to Glucantime
* Serious systemic illnesses (as judged by the physician)
* Participation in any drug trials in the last 60 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
60 Years
Study:
NCT00351520
Study Brief:
Protocol Section:
NCT00351520