Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-22 @ 7:23 AM
Study NCT ID:
NCT01806935
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xerotic Dermatitis in Aged People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 442}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-25', 'studyFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Itching symptoms intensity change', 'timeFrame': 'From Day 1 to 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['associated', 'aged population'], 'conditions': ['Itching Symptoms', 'Xerotic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged from 70 years\n* With xerotic dermatitis, clinically assessed ,\n* At least on the anterior part of lower and/or upper limbs,\n* Presenting itching xerotic dermatitis evolving from at least 3 weeks\n* Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time\n* With MMSE score ≥ 20 dating less than 6 months\n* Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation)\n\nExclusion Criteria:\n\n* Criteria related to pathologies\n\n * Severe form of other dermatitis requiring either systemic treatment\n\n \\-- Itching xerotic dermatitis from iatrogenic origins\n * Dermatological disease other than xerotic dermatitis which could interfere with the assessment,\n * Systemic disease that may generate xerotic dermatitis and /or pruritus\n * Immunosuppression condition,\n * History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.\n* Criteria related to treatment\n\n \\- Use of treatment which could interfere with the evaluation of the disease or the course of the disease\n* Criteria related to the population\n\n * Ongoing participation to another clinical trial or participation in the previous month before the inclusion\n * Patient under guardianship or trusteeship'}, 'identificationModule': {'nctId': 'NCT01806935', 'briefTitle': 'Xerotic Dermatitis in Aged People', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'orgStudyIdInfo': {'id': '2012-A01547-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DC086', 'description': 'cream', 'interventionNames': ['Device: DC086']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'DC086', 'type': 'DEVICE', 'armGroupLabels': ['DC086']}, {'name': 'Placebo', 'type': 'DEVICE', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': '0521', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Angers', 'country': 'France', 'facility': '0523', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Cugnaux', 'country': 'France', 'facility': '0520', 'geoPoint': {'lat': 43.53635, 'lon': 1.34428}}, {'city': 'Le Fousseret', 'country': 'France', 'facility': '0517', 'geoPoint': {'lat': 43.2818, 'lon': 1.06585}}, {'city': 'Muret', 'country': 'France', 'facility': '0518', 'geoPoint': {'lat': 43.45998, 'lon': 1.32541}}, {'city': 'Muret', 'country': 'France', 'facility': '0519', 'geoPoint': {'lat': 43.45998, 'lon': 1.32541}}, {'city': 'Saint-Orens-de-Gameville', 'country': 'France', 'facility': '0515', 'geoPoint': {'lat': 43.55182, 'lon': 1.53413}}, {'city': 'Saint-Orens-de-Gameville', 'country': 'France', 'facility': '0516', 'geoPoint': {'lat': 43.55182, 'lon': 1.53413}}, {'city': 'Seysses', 'country': 'France', 'facility': '0511', 'geoPoint': {'lat': 43.49801, 'lon': 1.31081}}, {'city': 'Seysses', 'country': 'France', 'facility': '0512', 'geoPoint': {'lat': 43.49801, 'lon': 1.31081}}, {'city': 'Seysses', 'country': 'France', 'facility': '0513', 'geoPoint': {'lat': 43.49801, 'lon': 1.31081}}, {'city': 'Seysses', 'country': 'France', 'facility': '0514', 'geoPoint': {'lat': 43.49801, 'lon': 1.31081}}, {'city': 'Tiercé', 'country': 'France', 'facility': '0522', 'geoPoint': {'lat': 47.6157, 'lon': -0.46787}}, {'city': 'Toulouse', 'country': 'France', 'facility': '0501', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Yves Rolland', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Purpan CHU TOULOUSE, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}