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

Purpose

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

Condition	Intervention	Phase
Uremic Xerosis	Drug: V0034CR01B Drug: V0034CR01B vehicle	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

Further study details as provided by Orfagen:

Primary Outcome Measures:

Long-term efficacy of V0034 CR 01B cream on uraemic xerosis in the real-life setting. [ Time Frame: 49 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local tolerance of V0034 CR 01B after long-term use and patient's benefit and acceptability of V0034 CR 01B [ Time Frame: 133 days ] [ Designated as safety issue: Yes ]

Enrollment:	236
Study Start Date:	January 2007
Study Completion Date:	March 2009

Arms	Assigned Interventions
Experimental: V0034CR01B cream	Drug: V0034CR01B
Placebo Comparator: V0034 CR 01B vehicle cream	Drug: V0034CR01B vehicle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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
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 -

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Dr Patrick DUPUY, MD, ORFAGEN
ClinicalTrials.gov Identifier:	NCT01084148 History of Changes
Other Study ID Numbers:	V00034 CR 308 ORF
Study First Received:	March 9, 2010
Last Updated:	March 9, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: MINISTRY OF HEALTH AND SOCIAL SOLIDARITY NATIONAL DRUG ORGANIZATION (EOF) Hungary: National Institute of Pharmacy Latvia: State Agency of Medicines Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Czech Republic: State Institute for Drug Control

ClinicalTrials.gov processed this record on May 16, 2013