Uremic Xerosis
Conditions
Brief 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. To assess the local tolerance of V0034 CR 01B after long-term use 2. To assess the patient benefit and acceptability of V0034 CR 01B
Interventions
DRUGV0034CR01B
DRUGV0034CR01B vehicle
Sponsors
Orfagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of both sexes, of at least 18 years of age 2. Women of childbearing potential having a reliable contraceptive method 3. Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure 4. Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis) 5. 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)
Exclusion criteria
1. Patients under 18 years of age 2. Women with childbearing potential having a positive pregnancy test at baseline 3. Patients undergoing renal dialysis for another reason than chronic renal insufficiency 4. Patients whose xerosis is due to another reason than their MRD status 5. Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas) 6. Patients with a known history of allergy to one of the ingredients contained in the test product 7. Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study 8. Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry 9. Patients who participated in a study within the three months prior to study entry 10. Patients who are not affiliated to health insurance 11. Patients who are not able or willing to follow the study instructions -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response of Xerosis | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | 133 days | 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 : 1. = very satisfactory 2. = satisfactory 3. = poorly satisfactory 4. = not satisfactory at all |
Participant flow
Pre-assignment details
Among the 237 enrolled patients: one patient not randomized. Among the 118 patients randomized into the V0034CR01B arm, one patient not treated. As such, among the 237 enrolled patients, 235 were treated, ie received test product at least once
Participants by arm
| Arm | Count |
|---|---|
| V0034CR01B cream
V0034CR01B | 118 |
| V0034 CR 01B Vehicle cream
V0034CR01B vehicle | 117 |
| Total | 235 |
Baseline characteristics
| Characteristic | V0034CR01B | V0034 CR 01B Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years | 64.5 years | 64.65 years |
| Sex: Female, Male Female | 48 Participants | 53 Participants | 101 Participants |
| Sex: Female, Male Male | 70 Participants | 64 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 118 | 39 / 117 |
| serious Total, serious adverse events | 16 / 118 | 19 / 117 |
Outcome results
Primary
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 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).
Time frame: 28 days
Population: One patient in V0034 CR 01B Vehicle arm randomized but not treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V0034CR01B | Treatment Response of Xerosis | 71 participants |
| V0034 CR 01B Vehicle | Treatment Response of Xerosis | 48 participants |
Secondary
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 : 1. = very satisfactory 2. = satisfactory 3. = poorly satisfactory 4. = not satisfactory at all
Time frame: 133 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V0034CR01B | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Satisfactory | 26 participants |
| V0034CR01B | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Not satisfactory at all | 6 participants |
| V0034CR01B | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Poorly satisfactory | 5 participants |
| V0034CR01B | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | No answer | 13 participants |
| V0034CR01B | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Very satistactory | 68 participants |
| V0034 CR 01B Vehicle | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | No answer | 3 participants |
| V0034 CR 01B Vehicle | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Very satistactory | 77 participants |
| V0034 CR 01B Vehicle | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Satisfactory | 32 participants |
| V0034 CR 01B Vehicle | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Poorly satisfactory | 4 participants |
| V0034 CR 01B Vehicle | Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | Not satisfactory at all | 1 participants |