Treatment of cutaneous leishmaniasis with meglumine antimoniate and allopurinol.

Recruiting

• Conditions: cutaneous leishmaniasis; Skin - Dermatological conditions

• Registration Number: ACTRN12607000295448
• Lead Sponsor: Dr Amer Ejaz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

2. Cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring systemic therapy.283. Positive parasitological diagnosis for cutaneous leishmaniasis.4. Patients that voluntarily accept to participate in the study and sign the informed consent.5. Disposition to be admitted to hospital, if necessary, and to attend all the visits punctually (initial, treatment and follow up).6. Acceptation of not using any other treatment for cutaneous leishmaniasis while in the study.

Exclusion Criteria

1. Pregnant women.2. Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of cutaneous leishmaniasis.3. Diffuse cutaneous leishmaniasis.4. Visceral leishmaniasis.5. Complete or incomplete treatment with antimony compounds in the last three months.6. Patients with history of hepatic, renal, or cardiovascular disease.7. Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete reepithelization [3 months after the beginning of the treatment.];Absence of reactivation and affections of the mucous membrane during the 6 months of the study. [The lesion size and induration will be measured every week during the treatment phase (28 days), thereafter once monthly during the follow up phase to assess the increase/decrease in the size of lesions.]

Secondary Outcome Measures

Name	Time	Method
Incomplete reepithelization[Three months after the beginning of the treatment.];Increase in the size of the ulcer by more than 50% in relation to the last clinical evaluation.[];Reactivation and/or affections of the mucous membranes during the 6 months of the study. [Study patients will be evaluated once weekly for ulcer size, induration and mucous membrane involvement, during the treatment period. In the follow up period patients will have monthly visits to record the parameters for 6 months.]