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

This study has been completed.
Sponsor:
Information provided by:
Orfagen
ClinicalTrials.gov Identifier:
NCT01084720
First received: March 9, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted

March 9, 2010
March 9, 2010
December 2002
Not Provided
Severity of uremic xerosis on the lower legs on day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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).
Same as current
No Changes Posted
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis
Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)
  • 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Uremic Xerosis
Drug: V0034 CR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2003
Not Provided

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
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01084720
V00034 CR 302 (ORF)
No
Dr Patrick Dupuy, MD, Orfagen
Orfagen
Not Provided
Principal Investigator: Jacek Szepietowski, Professor DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND
Orfagen
March 2010

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