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OpenTrials
Completed

NCT Number: NCT01084148

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

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Key information

Conditions

Uremic Xerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

V0034CR01B

Drug

V0034CR01B vehicle

Drug

Primary outcomes

  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

    • = 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 outcomes

  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 :

    • = very satisfactory
    • = satisfactory
    • = poorly satisfactory
    • = not satisfactory at all

Sponsors and collaborators

Lead sponsor

Orfagen

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2010
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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