Olive Oil With Omega 3 to Treat Stasis Dermatitis | NCT00421161

Studies
Olive Oil With Omega 3 to Treat Stasis Dermatitis

NCT00421161

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Jan 11, 2007Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Dermatitis

Interventions

olive oil and omega 3 in a combined cream

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Mar 2007

First Submitted Date

Jan 10, 2007

First Submission Date that Met QC Criteria

Jan 10, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2007

Last Update Posted Date

Jan 11, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
olive oil and omega 3 in a combined cream	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patints with stasis dermatitis for 6 months at least

Exclusion Criteria:

skin ulceration or infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Refael Segal, MD, Prof'	Contact	972-8-9258640-3		rsegal@post.tau.ac.il
Arie Bas, MD, Prof	Contact	972-8-9779188		arbas@post.tau.ac.il

Overall Officials

Name	Affiliation	Role
Arie Bass, MD	Assaf Harofe MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofe MC		Ẕerifin	Beer Yaacov	70300	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16130045	Background	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.

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D000069463	Olive Oil
D004281	Docosahexaenoic Acids

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids