Olive Oil With Omega 3 to Treat Stasis Dermatitis

January 10, 2007 updated by: Assaf-Harofeh Medical Center

Phase 1 and 2 Study on the Efficacy and Side Effects of Olive Oil and Omega 3 Local Treatment in Stasis Dermatitis

Olive oil and Omega 3 have many anti inflammatory effects that may be beneficial in the inflammation and edema of chronic stasis dermatitis. The olive oil contains many mono unsaturated fatty acids and anti oxidants that may add to the well being of a diseased skin by improving cell membrane homeostasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with chronic stasis dermatitis due to venous insufficiency will be treated with the study cream and as control we will use "Venoroutone" . Patients will be followed weekly at the clinic of the vascular surgery at Assaf Harofeh MC.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Clinic of vascular surgery, Assaf Harofe MC
        • Principal Investigator:
          • Arie Bass, MD
      • Zerifin, Israel, 70300
        • Clinic of Vascular Surgery
        • Contact:
    • Beer Yaacov
      • Zerifin, Beer Yaacov, Israel, 70300
        • Assaf Harofe MC
        • Contact:
        • Principal Investigator:
          • Arie Bas, MD

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patints with stasis dermatitis for 6 months at least

Exclusion Criteria:

  • skin ulceration or infection

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement,

Collaborators and Investigators

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

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Arie Bass, MD, Assaf Harofe MC

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

January 1, 2007

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

January 11, 2007

Last Update Submitted That Met QC Criteria

January 10, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Refael Segal

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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