Uremic XerosisPhase 3NCT01084720
Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis
A Phase 3 study testing V0034 CR in people with Uremic Xerosis, run by Orfagen.
Trial summary
To evaluate the palliative effects of a moisturising emollient, in patients with uremic xerosis of moderate, severe or very severe intensity, associated or not to uremic pruritus. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Uremic Xerosis
- What is being tested?
- V0034 CR
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Dec 2003
- Phase
- Phase 3
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes, of at least 10 years of age
- Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure
- Patients whose xerosis is related to their renal insufficiency status
- Patients suffering from moderate to severe xerosis, i.e. with a severity score of at least 2, on two symmetric areas of the lower legs (Phase I test areas)
- Patients who have not experienced phototherapy within 8 weeks prior to study entry
- Patients with no antipruritic treatment, or with stable antipruritic treatments (e.g. antihistamines, cholestyramine, opioid inhibitors, charcoal) at least 4 weeks before study entry
- Written informed consent (Appendix II) from the patients or parents
Who cannot join
- Patients under 10 years of age
- Patients undergoing renal dialysis for another reason than MRD
- Patients whose xerosis or pruritus is due to another reason than their MRD status
- Patients suffering from mild xerosis (score £ 1) on the lower legs
- Patients with xerosis of non comparable severity between the lower legs
- Patients with a known history of allergy to one of the ingredients contained in the test product
Show all 13Show fewer
- Patient with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
- Patients treated with any other emollient/moisturizing topical preparation within the 7 days prior to study entry
- Patients with phototherapy within 8 weeks prior to study entry
- Patients who started an antipruritic treatment other than phototherapy, or who experienced unstable dosage schedule of antipruritic treatments (e.g. antihistamines, cholestyramin, opiod inhibitors, charcoal) within 4 weeks prior to study entry
- Patients who participated in a study within the 3 months prior to study entry
- Patients who are not able or willing to follow the study instructions
- Patients or parents who refuse to give written informed consent
About this study
Official title: Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)
- To evaluate the palliative effects of a moisturising emollient, in patients with uremic xerosis of moderate, severe or very severe intensity, associated or not to uremic pruritus.
- To assess the local tolerance of the test product and its vehicle, and to evaluate the overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.
- Conditions
- Uremic Xerosis
- Being tested
- V0034 CR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0034 CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of uremic xerosis on the lower legs on day 7
Severity of uremic xerosis on the lower legs on day 7 by the investigator, using a defined 5-point severity scale. A therapeutic response was defined as a decrease of at least 2 grades of the xerosis after 7 days (end of phase I).
Measured: 7 days
Secondary outcomes (1)
Local tolerance of the test product and its vehicle and overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startDec 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic XerosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orfagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacek Szepietowski, Professor, Principal investigator, DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084720
- Sponsor's protocol ID
- V00034 CR 302 (ORF)
- Status last verified
- Mar 2010
- First submitted
- 9 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)
- ClinicalTrials.gov ID
- NCT01084720
- Acronym / sponsor ID
- V00034 CR 302 (ORF)
- Conditions
- Uremic Xerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- OrfagenIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Dec 2003 (actual)
- First posted
- 10 Mar 2010 (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.
- To evaluate the palliative effects of a moisturising emollient, in patients with uremic xerosis of moderate, severe or very severe intensity, associated or not to uremic pruritus.
- To assess the local tolerance of the test product and its vehicle, and to evaluate the overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes, of at least 10 years of age
- Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure
- Patients whose xerosis is related to their renal insufficiency status
- Patients suffering from moderate to severe xerosis, i.e. with a severity score of at least 2, on two symmetric areas of the lower legs (Phase I test areas)
- Patients who have not experienced phototherapy within 8 weeks prior to study entry
Key exclusion criteria (13 listed)
- Patients under 10 years of age
- Patients undergoing renal dialysis for another reason than MRD
- Patients whose xerosis or pruritus is due to another reason than their MRD status
- Patients suffering from mild xerosis (score £ 1) on the lower legs
- Patients with xerosis of non comparable severity between the lower legs
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 |
|---|---|---|
| V0034 CR | Drug | – |
Primary outcome
Severity of uremic xerosis on the lower legs on day 7
Time frame: 7 days
Severity of uremic xerosis on the lower legs on day 7 by the investigator, using a defined 5-point severity scale. A therapeutic response was defined as a decrease of at least 2 grades of the xerosis after 7 days (end of phase I).
1 secondary outcome
Local tolerance of the test product and its vehicle and overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
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.
Jacek Szepietowski, Professor principal investigator
DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V0034 CR in people with Uremic Xerosis, run by Orfagen.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 10 Mar 2010. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Severity of uremic xerosis on the lower legs on day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
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 10 Mar 2010.