Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients

• Conditions: Cutaneous Leishmaniasis
• Interventions: Drug: Pentostam

• Registration Number: NCT02281669
• Lead Sponsor: Sheba Medical Center

Brief Summary

Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.

Detailed Description

Cutaneous leishmaniasis is usually treated by topical intervention. In more severe cases intralesional Pentostam injection may be applied. This treatment is extremely efficient but painful, however without the known adverse effects of IV Pentostam treatment.

In this study the investigators will follow systematically all leishmania patients who are receiving the intralesional treatment. A structured questionnaire will be filled up in each doctor visit.

The current study goal is to examine the adverse effects and the patient reaction to this treatment, and to follow the recovery of lesion(s) after this treatment including the number of IL injections which was needed.

Study Timeline

• Status Verified: 2014-10
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-10-30
• Last Update Submitted: 2014-10-30
• Study Start: 2014-11
• Study First Posted: 2014-11-02
• Last Update Posted: 2014-11-02
• Primary Completion: 2016-11
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Cutaneous leishmaniasis patients
• Treatment by IL Pentostam
• Age above 18 years

Exclusion Criteria

• Children and pregnant women will not participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Research group	Pentostam	The study group includes all CL cases for whom the treating physician decides to treat by IL Pentostam. The patients will return to follow up and additional treatment every 3 weeks until full recovery \[as our current policy\].

Primary Outcome Measures

Name	Time	Method
Adverse effects	1 year	The adverse effects of IL Pentostam treatment will be monitored during the follow up period.

Secondary Outcome Measures

Name	Time	Method
Lesion healing	1 year	Lesions number and size will be recorded and response to treatment will be monitored.

Trial Locations

Locations (1)

Center of Geographic Medicine; 🇮🇱 Tel Hashomer, Israel