Randomized trial of local injections for cutaneousleishmaniasis caused by L. tropica

Phase 3

• Conditions: eishmania.; B55.1; Cutaneous leishmaniasis

• Registration Number: IRCT20081130001475N13
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

80-70 year old patients with clinically suspected CL lesion(s) with Parasitological proven (smear and/or culture) CL patients caused by L. tropica were recruited into the study if they met other eligibility criteria. Polymers chain reaction (PCR) was performed on every sample to assure that the lesion was caused by L. tropica. Other inclusion criteria were age 8-70 years, willingness to participate in the trial, and sign an informed consent and an oral assent from the children.

Exclusion Criteria

Patients with lesion(s) duration more than 6 months, more than 4 lesions, ulcer size more than 3 cm, lesions on the face or close to a vital organ, pregnant and nursing patients, those with a history of previous systemic or IL treatment with MA or those with an acute or chronic disease that could affect the course of CL or treatment with IL-MA injections were excluded.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome of the study was complete cure defined as complete re-epithelialization of the lesion with no induration. Timepoint: Before the intervention and every week. Method of measurement: Measurement of the lesion.