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

Cutaneous Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02281669
• Other study ID #: SHEBA-14-1571-ES-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 30, 2014
• Last updated: October 30, 2014
• Start date: November 2014
• Est. completion date: January 2017

Study information

• Verified date: October 2014
• Source: Sheba Medical Center
• Contact: Eli Schwartz, M.D, DTMH
• Phone: +97235308456
• Email: Eli.schwartz[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Pentostam
Intralesional injection of Pentostam

Locations

Country	Name	City	State
Israel	Center of Geographic Medicine	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects	The adverse effects of IL Pentostam treatment will be monitored during the follow up period.	1 year	No
Secondary	Lesion healing	Lesions number and size will be recorded and response to treatment will be monitored.	1 year	No