Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-28 @ 6:54 PM
Study NCT ID:
NCT00712868
Status:
COMPLETED
Last Update Posted:
2009-07-20
First Post:
2008-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability of Lactacyd Femina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019344', 'term': 'Lactic Acid'}], 'ancestors': [{'id': 'D007773', 'term': 'Lactates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 559}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-17', 'studyFirstSubmitDate': '2008-07-07', 'studyFirstSubmitQcDate': '2008-07-09', 'lastUpdatePostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and local tolerability', 'timeFrame': 'After 21 days'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'To demonstrate the safety and acceptability of the gynaecological formulation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Integral skin in the tested region\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding women\n* Use of anti-inflammatory or immune-suppression drugs\n* Topical medication use at the tested region\n* Active cutaneous gynaecological disease which may interfere in study results\n* Personal history of allergic disease at the area to be treated\n* Allergic or atopic history\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00712868', 'acronym': 'LACTAFEM', 'briefTitle': 'Acceptability of Lactacyd Femina', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina', 'orgStudyIdInfo': {'id': 'LACAC_L_03447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lactic Acid once a day during 21 days', 'interventionNames': ['Drug: Lactic acid']}], 'interventions': [{'name': 'Lactic acid', 'type': 'DRUG', 'description': 'Once a day', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Col. Coyoacan', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office'}], 'overallOfficials': [{'name': 'Judith Diaz, Md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}