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

NCT ID: NCT01084720

Last Updated: 2010-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2003-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

V0034 CR

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orfagen

INDUSTRY

Sponsor Role: lead

Responsible Party

Orfagen

Principal Investigators

Jacek Szepietowski, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

V00034 CR 302 (ORF)

Identifier Type: -

Identifier Source: org_study_id