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OpenTrials
Completed

NCT Number: NCT01084720

Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis

* To evaluate the palliative effects of a moisturising emollient, in patients with uremic xerosis of moderate, severe or very severe intensity, associated or not to uremic pruritus. * To assess the local tolerance of the test product and its vehicle, and to evaluate the overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.

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Key information

Conditions

Uremic Xerosis

Age range

10 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 10 years of age
  • Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure
  • Patients whose xerosis is related to their renal insufficiency status
  • Patients suffering from moderate to severe xerosis, i.e. with a severity score of at least 2, on two symmetric areas of the lower legs (Phase I test areas)
  • Patients who have not experienced phototherapy within 8 weeks prior to study entry
  • Patients with no antipruritic treatment, or with stable antipruritic treatments (e.g. antihistamines, cholestyramine, opioid inhibitors, charcoal) at least 4 weeks before study entry
  • Written informed consent (Appendix II) from the patients or parents

Exclusion criteria

  • Patients under 10 years of age
  • Patients undergoing renal dialysis for another reason than MRD
  • Patients whose xerosis or pruritus is due to another reason than their MRD status
  • Patients suffering from mild xerosis (score £ 1) on the lower legs
  • Patients with xerosis of non comparable severity between the lower legs
  • Patients with a known history of allergy to one of the ingredients contained in the test product
  • Patient with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
  • Patients treated with any other emollient/moisturizing topical preparation within the 7 days prior to study entry
  • Patients with phototherapy within 8 weeks prior to study entry
  • Patients who started an antipruritic treatment other than phototherapy, or who experienced unstable dosage schedule of antipruritic treatments (e.g. antihistamines, cholestyramin, opiod inhibitors, charcoal) within 4 weeks prior to study entry
  • Patients who participated in a study within the 3 months prior to study entry
  • Patients who are not able or willing to follow the study instructions
  • Patients or parents who refuse to give written informed consent

Treatment and study plan

V0034 CR

Drug

Primary outcomes

  1. Severity of uremic xerosis on the lower legs on day 7

    Time frame: 7 days

    Severity of uremic xerosis on the lower legs on day 7 by the investigator, using a defined 5-point severity scale. A therapeutic response was defined as a decrease of at least 2 grades of the xerosis after 7 days (end of phase I).

Secondary outcomes

  1. Local tolerance of the test product and its vehicle and overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

Orfagen

Industry

Registry information

Official study title

Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)

Important dates

Study start
2002
Study completion
2003
First posted
Mar 10, 2010
Registry last updated
Mar 10, 2010

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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