Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-01 @ 7:40 AM
Study NCT ID:
NCT00497692
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2007-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C018577', 'term': 'lactoserum'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2008-05-19', 'studyFirstSubmitDate': '2007-07-06', 'studyFirstSubmitQcDate': '2007-07-06', 'lastUpdatePostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)', 'timeFrame': 'six weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina Delicata.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Phototypes: I, II, III and IV\n* Integral skin test in the region\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding women\n* Use of antinflammatory or immune-suppression drugs\n* Personal history of atopy\n* History of sensibilization or irritation for topic products\n* Active cutaneous disease\n* Use of new drugs and/or cosmetics during the study\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00497692', 'briefTitle': 'Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) for Dermacyd Femina Delicata', 'orgStudyIdInfo': {'id': 'LACTO_L_02948'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lactoserum', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-aventis', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Jaderson Lima', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}