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Olive Oil With Omega 3 to Treat Stasis Dermatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00421161
First received: January 10, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dermatitis
 Drug: olive oil and omega 3 in a combined cream
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 1 and 2 Study on the Efficacy and Side Effects of Olive Oil and Omega 3 Local Treatment in Stasis Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

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

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patints with stasis dermatitis for 6 months at least

Exclusion Criteria:

  • skin ulceration or infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421161

Contacts
Contact: Refael Segal, MD, Prof` 972-8-9258640-3 rsegal@post.tau.ac.il
Contact: Arie Bas, MD, Prof 972-8-9779188 arbas@post.tau.ac.il

Locations
Israel
Assaf Harofe MC Not yet recruiting
Zerifin, Beer Yaacov, Israel, 70300
Contact: Refael Segal, MD     972-8-9258640-3     rsegal@post.tau.ac.il    
Principal Investigator: Arie Bas, MD            
Clinic of Vascular Surgery Not yet recruiting
Zerifin, Israel, 70300
Contact: Refael Segal, MD     972-8-9258640-3     rsegal@post.tau.ac.il    
Clinic of vascular surgery, Assaf Harofe MC Not yet recruiting
Zerifin, Israel, 70300
Principal Investigator: Arie Bass, MD            
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Arie Bass, MD Assaf Harofe MC
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00421161     History of Changes
Other Study ID Numbers: Refael Segal
Study First Received: January 10, 2007
Last Updated: January 10, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
olive oil
stasis dermatitis
Patients with stasis dermatitis for at least six months.

Additional relevant MeSH terms:
Dermatitis
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013