NCT00421161

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 11, 2007

Status Verified

January 1, 2007

First QC Date

January 10, 2007

Last Update Submit

January 10, 2007

Conditions

Dermatitis

Keywords

olive oilstasis dermatitisPatients with stasis dermatitis for at least six months.

Outcome Measures

Primary Outcomes (1)

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

Interventions

olive oil and omega 3 in a combined creamDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patints with stasis dermatitis for 6 months at least

You may not qualify if:

  • skin ulceration or infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Assaf Harofe MC

Ẕerifin, Beer Yaacov, 70300, Israel

Location

Clinic of vascular surgery, Assaf Harofe MC

Ẕerifin, Zerifin, 70300, Israel

Location

Clinic of Vascular Surgery

Ẕerifin, Zerifin, 70300, Israel

Location

Related 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.

    PMID: 16130045BACKGROUND

MeSH Terms

Conditions

Dermatitis

Interventions

Olive OilDocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFatty Acids, Omega-3Fatty Acids, UnsaturatedFatty AcidsFish Oils

Study Officials

  • Arie Bass, MD

    Assaf Harofe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Refael Segal, MD, Prof'

CONTACT

972-8-9258640-3rsegal@post.tau.ac.il

Arie Bas, MD, Prof

CONTACT

972-8-9779188arbas@post.tau.ac.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

January 1, 2007

Study Completion

March 1, 2007

Last Updated

January 11, 2007

Record last verified: 2007-01

Locations

IL(3)