Uremic XerosisPhase 3NCT01084148
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
A Phase 3 study testing V0034CR01B in people with Uremic Xerosis, run by Orfagen.
Trial summary
Primary objective: To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting. Secondary objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremic Xerosis
- What is being tested?
- V0034CR01B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, of at least 18 years of age
- Women of childbearing potential having a reliable contraceptive method
- Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
- Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
- Patients suffering from xerosis with a severity score of at least two, on at least one of the five tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck)
Who cannot join
- Patients under 18 years of age
- Women with childbearing potential having a positive pregnancy test at baseline
- Patients undergoing renal dialysis for another reason than chronic renal insufficiency
- Patients whose xerosis is due to another reason than their MRD status
- Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas)
- Patients with a known history of allergy to one of the ingredients contained in the test product
Show all 11Show fewer
- Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
- Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry
- Patients who participated in a study within the three months prior to study entry
- Patients who are not affiliated to health insurance
- Patients who are not able or willing to follow the study instructions -
About this study
Primary objective:
To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.
Secondary objectives:
- To assess the local tolerance of V0034 CR 01B after long-term use
- To assess the patient benefit and acceptability of V0034 CR 01B
- Conditions
- Uremic Xerosis
- Being tested
- V0034CR01B, V0034CR01B vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0034CR01BDrug
V0034CR01B vehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| V0034CR01B | Experimental | cream Receives: Drug: V0034CR01B |
| V0034 CR 01B vehicle | Placebo comparator | cream Receives: Drug: V0034CR01B vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response of Xerosis
Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale:
0 = smooth skin
- = patches of fine, powdery scales
- = diffuse ashy appearance with many fine scales
- = moderate scaling with beginning cracks
- = intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I).
Measured: 28 days
Secondary outcomes (1)
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B
At the end of treatment (day 133), patients assessed their overall agreement on the local tolerance of the test product, using a 4-point scale, as follows :
- = very satisfactory
- = satisfactory
- = poorly satisfactory
- = not satisfactory at all
Measured: 133 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 startJan 2007
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orfagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084148
- Sponsor's protocol ID
- V00034 CR 308 ORF
- Status last verified
- Nov 2017
- First submitted
- 9 Mar 2010
- Last updated
- 20 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Szepietowski JC, Kemeny L, Mettang T, Arenberger P. Long-Term Efficacy and Tolerability of an Emollient Containing Glycerol and Paraffin for Moderate-to-Severe Uremic Xerosis: A Randomized Phase 3 Study. Dermatol Ther (Heidelb). 2024 Nov;14(11):3033-3046. doi: 10.1007/s13555-024-01287-w. Epub 2024 Oct 18.
PubMed 39422853
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
- ClinicalTrials.gov ID
- NCT01084148
- Acronym / sponsor ID
- V00034 CR 308 ORF
- Conditions
- Uremic Xerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- OrfagenIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 18 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.
Secondary objectives:
- To assess the local tolerance of V0034 CR 01B after long-term use
- To assess the patient benefit and acceptability of V0034 CR 01B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V0034CR01B | Experimental | Drug: V0034CR01Bcream |
| V0034 CR 01B vehicle | Placebo comparator | Drug: V0034CR01B vehiclecream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both sexes, of at least 18 years of age
- Women of childbearing potential having a reliable contraceptive method
- Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
- Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
- Patients suffering from xerosis with a severity score of at least two, on at least one of the five tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck)
Key exclusion criteria (11 listed)
- Patients under 18 years of age
- Women with childbearing potential having a positive pregnancy test at baseline
- Patients undergoing renal dialysis for another reason than chronic renal insufficiency
- Patients whose xerosis is due to another reason than their MRD status
- Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas)
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 |
|---|---|---|
| V0034CR01B | Drug | V0034CR01B |
| V0034CR01B vehicle | Drug | V0034 CR 01B vehicle |
Primary outcome
Treatment Response of Xerosis
Time frame: 28 days
Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale: 0 = smooth skin 1. = patches of fine, powdery scales 2. = diffuse ashy appearance with many fine scales 3. = moderate scaling with beginning cracks 4. = intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I).
1 secondary outcome
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B
Time frame: 133 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39422853Szepietowski JC, Kemeny L, Mettang T, Arenberger P. Long-Term Efficacy and Tolerability of an Emollient Containing Glycerol and Paraffin for Moderate-to-Severe Uremic Xerosis: A Randomized Phase 3 Study. Dermatol Ther (Heidelb). 2024 Nov;14(11):3033-3046. doi: 10.1007/s13555-024-01287-w. Epub 2024 Oct 18.
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 3 study testing V0034CR01B 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 5 inclusion and 11 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 20 Dec 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Response of Xerosis (time frame: 28 days). 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 NCT01084148, 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 20 Dec 2017.