Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT02281669
Status:
UNKNOWN
Last Update Posted:
2014-11-03
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: