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Olive Oil With Omega 3 to Treat Stasis Dermatitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421161

Locations
Israel
Assaf Harofe MC
Zerifin, Beer Yaacov, Israel, 70300
Clinic of vascular surgery, Assaf Harofe MC
Zerifin, Israel, 70300
Clinic of Vascular Surgery
Zerifin, Israel, 70300
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 December 07, 2016