DermatitisPhase 1/2NCT00421161
Olive Oil With Omega 3 to Treat Stasis Dermatitis
A Phase 1/2 study testing olive oil and omega 3 in a combined cream in people with Dermatitis, run by Assaf-Harofeh Medical Center at 3 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dermatitis
- What is being tested?
- olive oil and omega 3 in a combined cream
- How many people
- 30 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2007to Mar 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patints with stasis dermatitis for 6 months at least
Who cannot join
- skin ulceration or infection
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Assaf Harofe MC
Tsrifin, Beer Yaacov, 70300
Refael Segal, MD, 972-8-9258640-3, rsegal@post.tau.ac.il
Arie Bas, MD
Clinic of vascular surgery, Assaf Harofe MC
Tsrifin, Zerifin, 70300
Arie Bass, MD
Clinic of Vascular Surgery
Tsrifin, Zerifin, 70300
Refael Segal, MD, 972-8-9258640-3, rsegal@post.tau.ac.il
About this study
Official title: Phase 1 and 2 Study on the Efficacy and Side Effects of Olive Oil and Omega 3 Local Treatment in Stasis Dermatitis
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.
Read the 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.
- Conditions
- Dermatitis
- Being tested
- olive oil and omega 3 in a combined cream
- Keywords
- olive oil, stasis dermatitis, Patients with stasis dermatitis for at least six months.
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olive oil and omega 3 in a combined creamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Arie Bass, MD, Principal investigator, Assaf Harofe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421161
- Sponsor's protocol ID
- Refael Segal
- Status last verified
- Jan 2007
- First submitted
- 10 Jan 2007
- Last updated
- 11 Jan 2007
- Results posted
- No
Publications
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.
PubMed 16130045
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 and 2 Study on the Efficacy and Side Effects of Olive Oil and Omega 3 Local Treatment in Stasis Dermatitis
- ClinicalTrials.gov ID
- NCT00421161
- Acronym / sponsor ID
- Refael Segal
- Conditions
- Dermatitis
- Keywords
- olive oil, stasis dermatitis, Patients with stasis dermatitis for at least six months.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2007
- Study completion
- Mar 2007
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patints with stasis dermatitis for 6 months at least
Key exclusion criteria (1 listed)
- skin ulceration or infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olive oil and omega 3 in a combined cream | Drug | – |
Primary outcome
improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2007.
- Background: PubMed 16130045Sapino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Bass, MD principal investigator
Assaf Harofe MC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing olive oil and omega 3 in a combined cream in people with Dermatitis, run by Assaf-Harofeh Medical Center at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Refael Segal, MD, Prof' (972-8-9258640-3, rsegal@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement,. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2007; AzTrials last refreshed its copy on 7 Nov 2026.