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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V0034CR01B | Experimental | cream |
|
| V0034 CR 01B vehicle | Placebo Comparator | cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0034CR01B | Drug |
| ||
| V0034CR01B vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| 133 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39422853 | Derived | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | V0034CR01B | cream V0034CR01B |
| FG001 | V0034 CR 01B Vehicle | cream V0034CR01B vehicle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 patient not randomised
1 patient in V0034 CR 01B vehicle group not treated
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| ID | Title | Description |
|---|---|---|
| BG000 | V0034CR01B | cream V0034CR01B |
| BG001 | V0034 CR 01B Vehicle | cream V0034CR01B vehicle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
| One patient in V0034 CR 01B Vehicle arm randomized but not treated | Posted | Number | participants | 28 days |
|
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Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V0034CR01B | cream V0034CR01B |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis allergic | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Orfagen | 0033 5 34 50 64 62 | caroline.miklaszewski@orfagen.com |
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|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| V0034 CR 01B Vehicle |
cream V0034CR01B vehicle |
|
|
| 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 :
| Posted | Number | participants | 133 days |
|
|
|
| 16 |
| 118 |
| 40 |
| 118 |
| EG001 | V0034 CR 01B Vehicle | cream V0034CR01B vehicle | 19 | 117 | 39 | 117 |
| Cellulitis | Infections and infestations |
|
| Sepsis | Infections and infestations |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications |
|
| Dialysis device complication | Injury, poisoning and procedural complications |
|
| fracture | Injury, poisoning and procedural complications |
|
| Shunt Thrombosis | Injury, poisoning and procedural complications |
|
| Spinal compression fracture | Injury, poisoning and procedural complications |
|
| Disseminated large cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Cerebrovascular accident | Nervous system disorders |
|
| Syncope | Nervous system disorders |
|
| Catheter removal | Surgical and medical procedures |
|
| Parathyroidectomy | Surgical and medical procedures |
|
| Renal transplant | Surgical and medical procedures |
|
| Aortic rupture | Vascular disorders |
|
| Acute myocardial infarction | Cardiac disorders |
|
| Bradycardia | Cardiac disorders |
|
| Coronary artery disease | Cardiac disorders |
|
| Left ventricular failure | Cardiac disorders |
|
| Colitis | Gastrointestinal disorders |
|
| Peritonitis | Gastrointestinal disorders |
|
| Necrosis | General disorders |
|
| Jaundice | Hepatobiliary disorders |
|
| Catheter related infection | Infections and infestations |
|
| Gangrene | Infections and infestations |
|
| Gastroenteritis | Infections and infestations |
|
| Osteomyelitis acute | Infections and infestations |
|
| Arteriovenous fistula anevrysm | Injury, poisoning and procedural complications |
|
| Carpal tunnel syndrome | Nervous system disorders |
|
| Transient ischaemic attack | Nervous system disorders |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
|
| Evidence based treatment | Surgical and medical procedures |
|
| Hospitalisation | Surgical and medical procedures |
|
| Therapeutic procedure | Surgical and medical procedures |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Anaemia | Blood and lymphatic system disorders |
|
| Angina pectoris | Cardiac disorders |
|
| Ankle fracture | Injury, poisoning and procedural complications |
|
| Anxiety | Psychiatric disorders |
|
| Application site erythema | General disorders |
|
| Application site irritation | General disorders |
|
| Application site pruritus | General disorders |
|
| Application site reaction | General disorders |
|
| Application site vesicles | General disorders |
|
| Arteriovenous fistule operation | Surgical and medical procedures |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Bacillus infection | Infections and infestations |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Blood pressure increased | Investigations |
|
| Bronchitis | Infections and infestations |
|
| Catheter site infection | Infections and infestations |
|
| Catheter site pruritus | General disorders |
|
| catheter site related reaction | General disorders |
|
| Clavicule fracture | Injury, poisoning and procedural complications |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Diabetic neuropathy | Nervous system disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Dry skin | Skin and subcutaneous tissue disorders |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders |
|
| Dysuria | Renal and urinary disorders |
|
| Erysipelas | Infections and infestations |
|
| Erythema | Skin and subcutaneous tissue disorders |
|
| Eye infection | Infections and infestations |
|
| Fluid retention | Metabolism and nutrition disorders |
|
| Gastrointestinal disorder | Gastrointestinal disorders |
|
| Haemodialysis-induces symptom | Injury, poisoning and procedural complications |
|
| Herpes simplex | Infections and infestations |
|
| Herpes zoster | Infections and infestations |
|
| Hyperkalaemia | Metabolism and nutrition disorders |
|
| Hyperparathyroidism secondary | Endocrine disorders |
|
| Hyperphosphataemia | Metabolism and nutrition disorders |
|
| Hypertension | Vascular disorders |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders |
|
| Hypotension | Vascular disorders |
|
| Inflammation | General disorders |
|
| Insomnia | Psychiatric disorders |
|
| Localised infection | Infections and infestations |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
|
| Nail infection | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Oesophagitis | Gastrointestinal disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Paronychia | Infections and infestations |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonia | Infections and infestations |
|
| Post-traumatic pain | Injury, poisoning and procedural complications |
|
| Procedural hypotension | Injury, poisoning and procedural complications |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders |
|
| Sinusitis | Infections and infestations |
|
| Skin infection | Infections and infestations |
|
| Sleep disorder | Psychiatric disorders |
|
| Upper respiratory tract infection | Infections and infestations |
|
| Urinary track infection | Infections and infestations |
|
| Vomiting | Gastrointestinal disorders |
|
| Wound infection | Infections and infestations |
|
Mutual agreement
| Poorly satisfactory |
|
| Not satisfactory at all |
|
| No answer |
|