Clinical trial comparing the utilization of Itraconazole and of Pentamidine for the treatment of Cutaneous Leishmaniasis in Amazonas

Not Applicable

• Conditions: Cutaneous Leishmaniasis; C03.752.300.500.400; B55.1

• Registration Number: RBR-3kjd8x
• Lead Sponsor: Fund. de Medicina Tropical Dr Heitor Vieira Dourado

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with Ulcerated Cutaneous Leishmaniasis, not previously treated; diagnosed through at least one of the following tests: direct examinations of the lesion, biopsy of the lesion, culture or polimerase chain reactions (PCR) positives to Leishmania guyanensis; age of 18-65 years old; both genders; presenting at least 1 to 3 ulcerated lesions, in any localization; lesion diameter between 1-5 cm; clinical evolution not inferior to 1 month and not superior to 3 months.

Exclusion Criteria

Evidence of severe underlying disease (heart, kidney, liver, lung) or malignant disease; immunodeficient or HIV-infected patients; severe protein and / or caloric malnutrition; any active and uncontrolled infectious disease, such as tuberculosis, leprosy, systemic fungal disease (histoplasmosis, paracoccidioidomycosis); pregnant or nursing women; history of previous treatment for leishmaniasis; inability or willingness to provide informed consent (patient and / or / legal representative); lack of availability for visits or to comply with study procedures; patients participating in another ongoing clinical study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Initial healing rate<br>;Clinical examination to evaluate the initial healing rate. Initial healing will be considered the complete epithelialization of the cutaneous lesions, in the absence of any inflammatory signs, 2 months after the drug treatment, by means visual clinical evaluation (physical medical exam).

Secondary Outcome Measures

Name	Time	Method
Final healing rate;Clinical examination to evaluate the final healing rate. Final healing will be considered the complete epithelialization of the cutaneous lesions, in the absence of any inflammatory signs, 6 months after the drug treatment, by means of visual clinical evaluation (physical medical exam).