Olive Oil With Omega 3 to Treat Stasis Dermatitis

Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00421161
• Other study ID #: Refael Segal
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 10, 2007
• Last updated: January 10, 2007
• Start date: January 2007
• Est. completion date: March 2007

Study information

• Verified date: January 2007
• Source: Assaf-Harofeh Medical Center
• Contact: Refael Segal, MD, Prof`
• Phone: 972-8-9258640-3
• Email: rsegal[@]post.tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patints with stasis dermatitis for 6 months at least

Exclusion Criteria:

• skin ulceration or infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema

Intervention

Drug:
• olive oil and omega 3 in a combined cream

Locations

Country	Name	City	State
Israel	Assaf Harofe MC	Zerifin	Beer Yaacov
Israel	Clinic of Vascular Surgery	Zerifin
Israel	Clinic of vascular surgery, Assaf Harofe MC	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement,