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
  Purpose
  • 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.

Condition Intervention Phase
Uremic Xerosis
Drug: V0034 CR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)

Further study details as provided by Orfagen:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: December 2002
Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084720

Sponsors and Collaborators
Orfagen
Investigators
Principal Investigator: Jacek Szepietowski, Professor DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND
  More Information

No publications provided

Responsible Party: Dr Patrick Dupuy, MD, Orfagen
ClinicalTrials.gov Identifier: NCT01084720     History of Changes
Other Study ID Numbers: V00034 CR 302 (ORF)
Study First Received: March 9, 2010
Last Updated: March 9, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014