Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis
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|ClinicalTrials.gov Identifier: NCT01084720|
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
- 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 or disease||Intervention/treatment||Phase|
|Uremic Xerosis||Drug: V0034 CR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)|
|Study Start Date :||December 2002|
|Actual Study Completion Date :||December 2003|
- Severity of uremic xerosis on the lower legs on day 7 [ Time Frame: 7 days ]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).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084720
|Principal Investigator:||Jacek Szepietowski, Professor||DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND|