Cutaneous leishmaniasis
Conditions
Interventions
This clinical trial will recruit male patients, with age of at least 18 years, who have up to five ulcers caused by Leishmania (Viannia) guyanensis. Thirty patients will be included and will take thre
Drug
D03.383.129.799.450
Sponsors
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
Fundação de Amparo à Pesquisa do Estado do Amazonas
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Male patient with eighteen years of age or more; bearer of American cutaneous leishmaniasis; caused by Leishmanis (Viannia) guyanensis; with up to five lesions; with no more than three months; without any mucosal disease and no previous treatment of the current episode of leishmanisasis
Exclusion criteria
Exclusion criteria: Exclusion criteria are: Refusal to participate in the project; Patients with liver disease; Patients with cardiac arrhythmias; Patients with hypertriglyceridemia; Patients with hypokalemia; recognized hypersensitivity to fluconazole; Presence of immunosuppression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete healing of the ulcer in a period of 60 days; verified by clinical examination, where complete epithelialization of the ulcer is identified; documented by measurement of the lesion and identification of the epithelialization, documented by photographic record, with statistical analysis of the percentage of cases with complete re-epithelialization of the ulcer;Primary outcomes expected for this project is complete healing of the ulcer in 60% of patients in the first phase of the project; with the finding of the total ulcer healing by clinical and photographic documentation; with results presented in percentage format after statistical analysis;After inclusion of 26 patients, only one showed complete healing of the ulcer within 60 days , making up 3.8 % of cases, indicating the suspension of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| permanent cure which is characterized by permanency of the fully healed injury for a period of 180 days; verified by clinical examination; with statistical analysis of the percentage of cases with complete re-epithelialization of the ulcer during 180 days Improvement is defined as a partial re-epithelialization of the ulcer better than 60% but less than 100% of the ulcer, in a period of 60 days; verified by clinical examination, which should observe the degree of ulcer re-epitelization, documented by photographic record; with statistical analysis of the percentage of cases defined as improvement Therapeutic failure is defined as re-epithelialization of less than 60% of the ulcer within 60 days; verified by clinical examination, which should observe the degree of re-epithelialization of the ulcer, documented by photographic record; with statistical analysis of the percentage of cases defined as therapeutic failure Recurrence is the resurgence of the ulcer, in the same place, after documented epithelialization; verified by clinical examination documented by photographic record; with statistical analysis of the percentage of cases defined as recurrence;Among the secondary outcomes, it is expected a final cure rate of 60%, with cases of failure, improvement and relapse, together with percentages below 40%;After inclusion of 26 patients , 25 ( 96.15 %) had treatment failure criteria , indicating the end of the study | — |
Countries
Brazil
Contacts
Public ContactValeska Francesconi
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
Outcome results
None listed