Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT01084720
Status:
COMPLETED
Last Update Posted:
2010-03-10
First Post:
2010-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-09', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of uremic xerosis on the lower legs on day 7', 'timeFrame': '7 days', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Local tolerance of the test product and its vehicle and overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.', 'timeFrame': '56 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uremic Xerosis']}, 'descriptionModule': {'briefSummary': '* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes, of at least 10 years of age\n* Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure\n* Patients whose xerosis is related to their renal insufficiency status\n* 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)\n* Patients who have not experienced phototherapy within 8 weeks prior to study entry\n* Patients with no antipruritic treatment, or with stable antipruritic treatments (e.g. antihistamines, cholestyramine, opioid inhibitors, charcoal) at least 4 weeks before study entry\n* Written informed consent (Appendix II) from the patients or parents\n\nExclusion Criteria:\n\n* Patients under 10 years of age\n* Patients undergoing renal dialysis for another reason than MRD\n* Patients whose xerosis or pruritus is due to another reason than their MRD status\n* Patients suffering from mild xerosis (score £ 1) on the lower legs\n* Patients with xerosis of non comparable severity between the lower legs\n* Patients with a known history of allergy to one of the ingredients contained in the test product\n* Patient with an intercurrent condition which may interfere with a good conduct or the study parameters of the study\n* Patients treated with any other emollient/moisturizing topical preparation within the 7 days prior to study entry\n* Patients with phototherapy within 8 weeks prior to study entry\n* 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\n* Patients who participated in a study within the 3 months prior to study entry\n* Patients who are not able or willing to follow the study instructions\n* Patients or parents who refuse to give written informed consent'}, 'identificationModule': {'nctId': 'NCT01084720', 'briefTitle': 'Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orfagen'}, 'officialTitle': 'Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)', 'orgStudyIdInfo': {'id': 'V00034 CR 302 (ORF)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'V0034 CR', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jacek Szepietowski, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orfagen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Patrick Dupuy, MD', 'oldOrganization': 'Orfagen'}}}}