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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orfagen
ClinicalTrials.gov Identifier:
NCT01084148
First received: March 9, 2010
Last updated: January 31, 2014
Last verified: January 2014
  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:

  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 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 (Subject, Investigator)
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:
  • Treatment Response of Xerosis [ Time Frame: 28 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: 237
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Orfagen
ClinicalTrials.gov Identifier: NCT01084148     History of Changes
Other Study ID Numbers: V00034 CR 308 ORF
Study First Received: March 9, 2010
Results First Received: January 31, 2014
Last Updated: January 31, 2014
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 April 15, 2014