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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: April 18, 2014
Last verified: April 2014

March 9, 2010
April 18, 2014
January 2007
January 2009   (final data collection date for primary outcome measure)
Treatment Response of Xerosis [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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).
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 ]
Complete list of historical versions of study NCT01084148 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Uremic Xerosis
  • Drug: V0034CR01B
  • Drug: V0034CR01B vehicle
  • Experimental: V0034CR01B
    cream
    Intervention: Drug: V0034CR01B
  • Placebo Comparator: V0034 CR 01B vehicle
    cream
    Intervention: Drug: V0034CR01B vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
March 2009
January 2009   (final data collection date for primary outcome measure)

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 -
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01084148
V00034 CR 308 ORF
No
Orfagen
Orfagen
Not Provided
Not Provided
Orfagen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP