Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis
This study has been completed.
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First received: March 9, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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 ]
|Study Start Date:||December 2002|
|Study Completion Date:||December 2003|
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