Uremic PruritusPhase 1/2NCT01447693
Treatment of Uremic Pruritus by Olive-omega 3 Ointment
A Phase 1/2 study testing application of ointment (olive-omega 3 ointment) in people with Uremic Pruritus, run by Assaf-Harofeh Medical Center.
Trial summary
Background. Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is regarded as one of the most bothersome symptoms in patients on chronic dialysis. The pathogenesis of uremic itch remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- application of ointment (olive-omega 3 ointment)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis patients which have treated at least 3 months
Who cannot join
- Dermatologic diseases
About this study
Background.
Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is regarded as one of the most bothersome symptoms in patients on chronic dialysis.
Read more
The pathogenesis of uremic itch remains unclear. Several theories have been proposed like dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.
Many treatment modalities have been tried to reduce uremic pruritus, however , the majority of them produced only temporary improvement. Therefore , every new therapeutic option for uremic pruritus is desirable.
This study will undertaken to evaluate the efficacy of a cream which included olive oil and omega-3 fatty acids.
Olive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.
The product is unique and based on patented technology developed by the Technion Research and Development Foundation in Haifa.
Olive Omega-3 is an ointment composed of all natural ingredients. The main active ingredients are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin with fatty acids that are vital for its proper functioning and help in the skin recovery. Sugar cane extract improves the skin's flexibility by removing dead cells and enhancing water retention in the upper layer of the skin.
When applied on clean skin , the product is quickly absorbed , producing a sensation of relief within a short time period. Treatment can be repeated as often as required with no limitations and its use is not contraindicative of any other medical treatment.
Patients and Methods.
About 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in the study.
All patients will undergo dermatologic examination. All patients will be score by intensity of itching according to 3-point scale , as follows:
- - patches of fine , powdery scales
- - moderate scaling with beginning cracks
- - intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for 50% of body and Vaseline ointment for the second one. The treatment will repeated twice daily for two weeks.
At the end of 2 weeks application global tolerance will evaluate using the following 3-point scale:
- very good
- good
- poor
At the same time global agreement of the patients will evaluate according to the following scale :
- - very satisfactory
- - satisfactory 3- poorly satisfactory.
Statistical analysis will be performed by use of Wilcoxon test .
- Conditions
- Uremic Pruritus
- Being tested
- application of ointment (olive-omega 3 ointment)
- Keywords
- uremia, pruritus, oliva-omega 3
- Medical subject headings
- Uremia, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of ointment (olive-omega 3 ointment)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic PruritusStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447693
- Sponsor's protocol ID
- 130/06
- Status last verified
- Oct 2011
- First submitted
- 31 Dec 2007
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Uremic Pruritus by Olive-omega 3 Ointment
- ClinicalTrials.gov ID
- NCT01447693
- Acronym / sponsor ID
- 130/06
- Conditions
- Uremic Pruritus
- Keywords
- uremia, pruritus, oliva-omega 3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 6 Oct 2011 (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.
Background.
Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is regarded as one of the most bothersome symptoms in patients on chronic dialysis.
The pathogenesis of uremic itch remains unclear. Several theories have been proposed like dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.
Many treatment modalities have been tried to reduce uremic pruritus, however , the majority of them produced only temporary improvement. Therefore , every new therapeutic option for uremic pruritus is desirable.
This study will undertaken to evaluate the efficacy of a cream which included olive oil and omega-3 fatty acids.
Olive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.
The product is unique and based on patented technology developed by the Technion Research and Development Foundation in Haifa.
Olive Omega-3 is an ointment composed of all natural ingredients. The main active ingredients are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin with fatty acids that are vital for its proper functioning and help in the skin recovery. Sugar cane extract improves the skin's flexibility by removing dead cells and enhancing water retention in the upper layer of the skin.
When applied on clean skin , the product is quickly absorbed , producing a sensation of relief within a short time period. Treatment can be repeated as often as required with no limitations and its use is not contraindicative of any other medical treatment.
Patients and Methods.
About 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in the study.
All patients will undergo dermatologic examination. All patients will be score by intensity of itching according to 3-point scale , as follows:
- - patches of fine , powdery scales
- - moderate scaling with beginning cracks
- - intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for 50% of body and Vaseline ointment for the second one. The treatment will repeated twice daily for two weeks.
At the end of 2 weeks application global tolerance will evaluate using the following 3-point scale:
- very good
- good
- poor
At the same time global agreement of the patients will evaluate according to the following scale :
- - very satisfactory
- - satisfactory 3- poorly satisfactory.
Statistical analysis will be performed by use of Wilcoxon test .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodialysis patients which have treated at least 3 months
Key exclusion criteria (1 listed)
- Dermatologic diseases
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 |
|---|---|---|
| application of ointment (olive-omega 3 ointment) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
Related trials for Uremic Pruritus
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), Hemodialysis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing application of ointment (olive-omega 3 ointment) in people with Uremic Pruritus, run by Assaf-Harofeh Medical Center.
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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 6 Oct 2011.