Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-29 @ 12:22 PM
Study NCT ID:
NCT00783861
Status:
COMPLETED
Last Update Posted:
2008-12-19
First Post:
2008-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2008-12-18', 'studyFirstSubmitDate': '2008-10-31', 'studyFirstSubmitQcDate': '2008-10-31', 'lastUpdatePostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.', 'timeFrame': 'Throughout the study'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofi-aventis.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic Acid) Pocket BR.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Age between 18 and 60 years old;\n* Phototype Skin I,II, III e IV\n* Integral skin test in the region;\n* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;\n\nExclusion criteria:\n\n* Lactation or gestation\n* Use of Antiinflammatory and/or immunosuppression drugs one month before the study;\n* Personnel history of atopy;\n* History of sensitivity or irritation for topic products;\n* Active cutaneous disease;\n* Use of new drugs 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': 'NCT00783861', 'briefTitle': 'Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Femina Pocket BR.', 'orgStudyIdInfo': {'id': 'LACAC_L_04370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lactic Acid (Dermacyd Femina)', 'interventionNames': ['Drug: Lactic Acid']}], 'interventions': [{'name': 'Lactic Acid', 'type': 'DRUG', 'description': 'Lactic Acid (Dermacyd Femina)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Jaderson Lima', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}