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

NCT01084720 | Completed Phase 3

• 1 other identifier: V00034 CR 302 (ORF)
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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.

Conditions

Uremic Xerosis

Outcome Measures

Primary Outcomes (1)

• Severity of uremic xerosis on the lower legs on day 7

  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).

  7 days

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.

  56 days

Interventions

V0034 CR DRUG

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orfagen: lead

Study Officials

• Jacek Szepietowski, Professor

  DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: December 1, 2002
• Study Completion: December 1, 2003
• Last Updated: March 10, 2010

Record last verified: 2010-03