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Olive Oil With Omega 3 to Treat Stasis Dermatitis

Primary Purpose

Dermatitis

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

olive oil and omega 3 in a combined cream

About this trial

This is an interventional treatment trial for Dermatitis focused on measuring olive oil, stasis dermatitis, Patients with stasis dermatitis for at least six months.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patints with stasis dermatitis for 6 months at least

Exclusion Criteria:

skin ulceration or infection

Sites / Locations

Assaf Harofe MC
Clinic of vascular surgery, Assaf Harofe MC
Clinic of Vascular Surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00421161

First Posted

January 10, 2007

Last Updated

January 10, 2007

Sponsor

Assaf-Harofeh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00421161

Brief Title

Olive Oil With Omega 3 to Treat Stasis Dermatitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Assaf-Harofeh Medical Center

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis

Keywords

olive oil, stasis dermatitis, Patients with stasis dermatitis for at least six months.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

olive oil and omega 3 in a combined cream

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patints with stasis dermatitis for 6 months at least Exclusion Criteria: skin ulceration or infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Refael Segal, MD, Prof'

Phone

972-8-9258640-3

rsegal@post.tau.ac.il

First Name & Middle Initial & Last Name or Official Title & Degree

Arie Bas, MD, Prof

Phone

972-8-9779188

arbas@post.tau.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arie Bass, MD

Organizational Affiliation

Assaf Harofe MC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assaf Harofe MC

City

Zerifin

State/Province

Beer Yaacov

ZIP/Postal Code

70300

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Refael Segal, MD

Phone

972-8-9258640-3

rsegal@post.tau.ac.il

First Name & Middle Initial & Last Name & Degree

Arie Bas, MD

Facility Name

Clinic of vascular surgery, Assaf Harofe MC

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arie Bass, MD

Facility Name

Clinic of Vascular Surgery

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Refael Segal, MD

Phone

972-8-9258640-3

rsegal@post.tau.ac.il

12. IPD Sharing Statement

Citations:

PubMed Identifier

16130045

Citation

Sapino S, Carlotti ME, Peira E, Gallarate M. Hemp-seed and olive oils: their stability against oxidation and use in O/W emulsions. J Cosmet Sci. 2005 Jul-Aug;56(4):227-51.

Results Reference

background

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Olive Oil With Omega 3 to Treat Stasis Dermatitis

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