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

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ClinicalTrials.gov Identifier: NCT01084148
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : March 18, 2014
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Orfagen

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 Type : Interventional  (Clinical Trial)
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 : January 2007
Primary Completion Date : January 2009
Study Completion Date : March 2009

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



Primary Outcome Measures :
  1. Treatment Response of Xerosis [ Time Frame: 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

    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).


Secondary Outcome Measures :
  1. Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B [ Time Frame: 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 :

    1. = very satisfactory
    2. = satisfactory
    3. = poorly satisfactory
    4. = not satisfactory at all



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 -

Responsible Party: Orfagen
ClinicalTrials.gov Identifier: NCT01084148     History of Changes
Other Study ID Numbers: V00034 CR 308 ORF
First Posted: March 10, 2010    Key Record Dates
Results First Posted: March 18, 2014
Last Update Posted: December 20, 2017
Last Verified: November 2017