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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02281669

Enrollment

100

Registered

2014-11-03

Start date

2014-11-30

Completion date

2017-01-31

Last updated

2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis

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.

Interventions

DRUGPentostam

Intralesional injection of Pentostam

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Lesion healing	1 year	Lesions number and size will be recorded and response to treatment will be monitored.

Countries

Israel

Contacts

Primary ContactEli Schwartz, M.D, DTMH

Eli.schwartz@sheba.health.gov.il+97235308456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026