Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.

December 30, 2016 updated by: Tel-Aviv Sourasky Medical Center

The investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.

Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be recruited.

Half of the lesions will be treated with intra-lesional injections of Pentostam, and the other half by CO2 laser with topical application of Pentostam.

Each lesion will recieve 3 treatments, one month apart between treatments. The patients will scale pain level of each treatment. Final scar appearance will be assessed by two dermatologists, without knowing what treatment was applied to each lesion.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Objective cutaneous leishmaniasis diagnosis.
  • More than one Lesion

Exclusion Criteria:

  • Previous treatment
  • Abnormal scarring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
CO2 fractional laser with local application of Pentostam
Drug: Local application pentostam
Device: fractional CO2 laser
ACTIVE_COMPARATOR: control
Intra-lesinal Pentostam injedction
Drug: intra-lisional pentostam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scar appearance
Time Frame: At sixth month
Each lesion will be photographed prior to treatment and at 6th month (Three months after last (3rd) treatment).Two dermatologist will asses each lesion outcome
At sixth month

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain assessed by VAS
Time Frame: at one month, two months, and three months
at one month, two months, and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (ESTIMATE)

January 4, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

December 30, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-14-OA-371-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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