Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

• Sponsor: Orfagen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01084148
• Collaborator: (none)
• Enrollment: 237
• Arms: 2
• Duration (Months): 26

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Uremic Xerosis	Drug: V0034CR01B; Drug: V0034CR01B vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 237 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: V0034CR01B cream	Drug: V0034CR01B
Placebo Comparator: V0034 CR 01B vehicle cream	Drug: V0034CR01B vehicle

Outcome Measures

Primary Outcome Measures

1. 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 = 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).

Secondary Outcome Measures

1. 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 : = very satisfactory = satisfactory = poorly satisfactory = not satisfactory at all

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Orfagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orfagen
• ClinicalTrials.gov Identifier: NCT01084148
• Other Study ID Numbers: V00034 CR 308 ORF
• First Posted: Mar 10, 2010
• Last Update Posted: Dec 20, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: V0034CR

Study Results

Participant Flow

Pre-assignment Detail	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

Arm/Group Title	V0034CR01B	V0034 CR 01B Vehicle
Arm/Group Description	cream V0034CR01B	cream V0034CR01B vehicle
Period Title: Overall Study
STARTED	118	118
Treated Patients	118	117
COMPLETED	88	102
NOT COMPLETED	30	16

Baseline Characteristics

Arm/Group Title	V0034CR01B	V0034 CR 01B Vehicle	Total
Arm/Group Description	cream V0034CR01B	cream V0034CR01B vehicle	Total of all reporting groups
Overall Participants	118	117	235
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	64.8	64.5	64.65
Sex: Female, Male (Count of Participants)
Female	48 40.7%	53 45.3%	101 43%
Male	70 59.3%	64 54.7%	134 57%

Outcome Measures

1. Primary Outcome

Title	Treatment Response of Xerosis
Description	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).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

One patient in V0034 CR 01B Vehicle arm randomized but not treated

Arm/Group Title	V0034CR01B	V0034 CR 01B Vehicle
Arm/Group Description	cream V0034CR01B	cream V0034CR01B vehicle
Measure Participants	118	117
Number [participants]	71 60.2%	48 41%

2. Secondary Outcome

Title	Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B
Description	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
Time Frame	133 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	V0034CR01B	V0034 CR 01B Vehicle
Arm/Group Description	cream V0034CR01B for 28 days (Period I), then treatment free-follow-up (up for 21 days if non persisting lesion and non relapsing lesions (Period II)), then V0034CR01B for 84 days (Period III)	cream V0034CR01B vehicle for 28 days (Period I), then treatment free-follow-up (up for 21 days if non persisting lesion and non relapsing lesions (Period II)), then V0034CR01B for 84 days (Period III)
Measure Participants	118	117
Very satistactory	68 57.6%	77 65.8%
Satisfactory	26 22%	32 27.4%
Poorly satisfactory	5 4.2%	4 3.4%
Not satisfactory at all	6 5.1%	1 0.9%
No answer	13 11%	3 2.6%

Adverse Events

Adverse Event Reporting Description	Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Arm/Group Title	V0034CR01B		V0034 CR 01B Vehicle
Arm/Group Description	cream V0034CR01B		cream V0034CR01B vehicle
All Cause Mortality
	V0034CR01B		V0034 CR 01B Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	V0034CR01B		V0034 CR 01B Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/118 (13.6%)		19/117 (16.2%)
Cardiac disorders
Acute myocardial infarction	0/118 (0%)		1/117 (0.9%)
Bradycardia	0/118 (0%)		1/117 (0.9%)
Coronary artery disease	0/118 (0%)		1/117 (0.9%)
Left ventricular failure	0/118 (0%)		1/117 (0.9%)
Gastrointestinal disorders
Colitis	0/118 (0%)		1/117 (0.9%)
Peritonitis	0/118 (0%)		3/117 (2.6%)
General disorders
Death	1/118 (0.8%)		0/117 (0%)
Necrosis	0/118 (0%)		1/117 (0.9%)
Hepatobiliary disorders
Jaundice	0/118 (0%)		1/117 (0.9%)
Infections and infestations
Cellulitis	1/118 (0.8%)		0/117 (0%)
Sepsis	1/118 (0.8%)		1/117 (0.9%)
Catheter related infection	0/118 (0%)		1/117 (0.9%)
Gangrene	0/118 (0%)		1/117 (0.9%)
Gastroenteritis	0/118 (0%)		1/117 (0.9%)
Osteomyelitis acute	0/118 (0%)		1/117 (0.9%)
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis	1/118 (0.8%)		0/117 (0%)
Dialysis device complication	1/118 (0.8%)		0/117 (0%)
fracture	1/118 (0.8%)		0/117 (0%)
Shunt Thrombosis	1/118 (0.8%)		3/117 (2.6%)
Spinal compression fracture	1/118 (0.8%)		0/117 (0%)
Arteriovenous fistula anevrysm	0/118 (0%)		1/117 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disseminated large cell lymphoma	1/118 (0.8%)		0/117 (0%)
Nervous system disorders
Cerebrovascular accident	1/118 (0.8%)		0/117 (0%)
Syncope	1/118 (0.8%)		0/117 (0%)
Carpal tunnel syndrome	0/118 (0%)		1/117 (0.9%)
Transient ischaemic attack	0/118 (0%)		2/117 (1.7%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/118 (0%)		1/117 (0.9%)
Surgical and medical procedures
Catheter removal	1/118 (0.8%)		0/117 (0%)
Parathyroidectomy	1/118 (0.8%)		0/117 (0%)
Renal transplant	4/118 (3.4%)		1/117 (0.9%)
Evidence based treatment	0/118 (0%)		4/117 (3.4%)
Hospitalisation	0/118 (0%)		5/117 (4.3%)
Therapeutic procedure	0/118 (0%)		1/117 (0.9%)
Vascular disorders
Aortic rupture	1/118 (0.8%)		0/117 (0%)
Other (Not Including Serious) Adverse Events
	V0034CR01B		V0034 CR 01B Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/118 (33.9%)		39/117 (33.3%)
Blood and lymphatic system disorders
Anaemia	1/118 (0.8%)		0/117 (0%)
Cardiac disorders
Angina pectoris	1/118 (0.8%)		0/117 (0%)
Endocrine disorders
Hyperparathyroidism secondary	0/118 (0%)		1/117 (0.9%)
Gastrointestinal disorders
Abdominal pain	0/118 (0%)		1/117 (0.9%)
Diarrhoea	1/118 (0.8%)		2/117 (1.7%)
Gastrointestinal disorder	0/118 (0%)		1/117 (0.9%)
Oesophagitis	1/118 (0.8%)		0/117 (0%)
Vomiting	1/118 (0.8%)		1/117 (0.9%)
General disorders
Application site erythema	0/118 (0%)		1/117 (0.9%)
Application site irritation	1/118 (0.8%)		3/117 (2.6%)
Application site pruritus	1/118 (0.8%)		2/117 (1.7%)
Application site reaction	1/118 (0.8%)		0/117 (0%)
Application site vesicles	2/118 (1.7%)		1/117 (0.9%)
Catheter site pruritus	1/118 (0.8%)		0/117 (0%)
catheter site related reaction	2/118 (1.7%)		0/117 (0%)
Inflammation	0/118 (0%)		1/117 (0.9%)
Infections and infestations
Bacillus infection	0/118 (0%)		1/117 (0.9%)
Bronchitis	0/118 (0%)		3/117 (2.6%)
Catheter site infection	2/118 (1.7%)		3/117 (2.6%)
Erysipelas	0/118 (0%)		1/117 (0.9%)
Eye infection	1/118 (0.8%)		0/117 (0%)
Herpes simplex	0/118 (0%)		1/117 (0.9%)
Herpes zoster	0/118 (0%)		1/117 (0.9%)
Localised infection	1/118 (0.8%)		0/117 (0%)
Nail infection	1/118 (0.8%)		1/117 (0.9%)
Nasopharyngitis	2/118 (1.7%)		1/117 (0.9%)
Paronychia	0/118 (0%)		1/117 (0.9%)
Pneumonia	0/118 (0%)		1/117 (0.9%)
Sinusitis	1/118 (0.8%)		0/117 (0%)
Skin infection	0/118 (0%)		1/117 (0.9%)
Upper respiratory tract infection	1/118 (0.8%)		0/117 (0%)
Urinary track infection	1/118 (0.8%)		4/117 (3.4%)
Wound infection	1/118 (0.8%)		0/117 (0%)
Injury, poisoning and procedural complications
Ankle fracture	1/118 (0.8%)		0/117 (0%)
Clavicule fracture	0/118 (0%)		1/117 (0.9%)
Haemodialysis-induces symptom	0/118 (0%)		2/117 (1.7%)
Post-traumatic pain	1/118 (0.8%)		0/117 (0%)
Procedural hypotension	0/118 (0%)		1/117 (0.9%)
Investigations
Blood pressure increased	1/118 (0.8%)		0/117 (0%)
Metabolism and nutrition disorders
Fluid retention	1/118 (0.8%)		0/117 (0%)
Hyperkalaemia	0/118 (0%)		1/117 (0.9%)
Hyperphosphataemia	0/118 (0%)		1/117 (0.9%)
Hypertriglyceridaemia	1/118 (0.8%)		0/117 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/118 (1.7%)		0/117 (0%)
Back pain	1/118 (0.8%)		2/117 (1.7%)
Musculoskeletal pain	1/118 (0.8%)		1/117 (0.9%)
Pain in extremity	2/118 (1.7%)		1/117 (0.9%)
Nervous system disorders
Diabetic neuropathy	1/118 (0.8%)		0/117 (0%)
Psychiatric disorders
Anxiety	0/118 (0%)		1/117 (0.9%)
Insomnia	1/118 (0.8%)		1/117 (0.9%)
Sleep disorder	0/118 (0%)		1/117 (0.9%)
Renal and urinary disorders
Dysuria	0/118 (0%)		1/117 (0.9%)
Respiratory, thoracic and mediastinal disorders
Cough	1/118 (0.8%)		1/117 (0.9%)
Pleurisy	0/118 (0%)		1/117 (0.9%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	1/118 (0.8%)		0/117 (0%)
Dry skin	1/118 (0.8%)		0/117 (0%)
Dyshidrosis	1/118 (0.8%)		0/117 (0%)
Erythema	0/118 (0%)		2/117 (1.7%)
Pruritus	2/118 (1.7%)		1/117 (0.9%)
Pruritus allergic	1/118 (0.8%)		0/117 (0%)
Pruritus generalised	2/118 (1.7%)		1/117 (0.9%)
Surgical and medical procedures
Arteriovenous fistule operation	0/118 (0%)		2/117 (1.7%)
Vascular disorders
Hypertension	1/118 (0.8%)		3/117 (2.6%)
Hypotension	1/118 (0.8%)		0/117 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Mutual agreement