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

Sheba Medical Center

Status: Unknown

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Pentostam

Study type: Observational

Funder types: Other

Identifiers

NCT02281669

SHEBA-14-1571-ES-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

100 participants in 1 patient group

Research group

Description:

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 \[as our current policy\].

Treatment:

Drug: Pentostam