Leishmaniasis Clinical Trial
Official title:
Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase as an Adjunct in Cutaneous Leishmaniasis Therapy: a Randomized and Controlled Trial
Verified date | September 2017 |
Source | Hospital Universitário Professor Edgard Santos |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the treatment of Cutaneous Leishmaniasis in Bahia, Brazil.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Newly diagnosed (untreated) cutaneous leishmaniasis or early cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test). - Number of lesions: 1 to 3 ulcerative lesions. - LesionĀ“s diameter: 1 to 5 cm. - Disease duration: up to three months. Exclusion Criteria: - Aspartate aminotransferase, alanine aminotransferase >3 times upper limit of normal range - Serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range - Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) - Immunodeficiency or antibody to HIV - Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases - Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months - Negative parasitology (aspirate/biopsy/PCR) or negative Montenegro test - Any history of prior anti-leishmania therapy - Any condition which compromises ability to comply with the study procedures - Lack of ability or willingness to give informed consent (patient and/or parent / legal representative) - Anticipated non-availability for study visits/procedure |
Country | Name | City | State |
---|---|---|---|
Brazil | Corte de Pedra Health Post | Corte de Pedra | Bahia |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitário Professor Edgard Santos | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia, Pontificia Universidade Católica do Rio Grande do Sul |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cure rate or complete cicatrization of the ulcer. | Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. |
6 months after treatment | |
Secondary | Initial cure rate or complete cicatrization of the ulcer. | Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. |
2 months after treatment |
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