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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02281669
Other study ID # SHEBA-14-1571-ES-CTIL
Secondary ID
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


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
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