Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 12:23 AM
Study NCT ID:
NCT00785850
Status:
COMPLETED
Last Update Posted:
2009-03-06
First Post:
2008-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Safety.
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': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-03-05', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.', 'timeFrame': 'From the treatment start to the end of the study'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'To prove the safety in normal conditions of use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Integral skin test in the region;\n* Use of cosmetic product of the same category;\n* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;\n\nExclusion criteria:\n\n* Lactation or gestational risk or gestation;\n* Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs;\n* Atopic antecedent or allergic to cosmetic product;\n* Active cutaneous disease in the evaluation area;\n* Diseases which cause immunology decrease, such as diabetes and HIV;\n* Endocrinal pathologies;\n* Intense solar exposure 15 days before the evaluation;\n* Treatment until four months before the selection\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00785850', 'briefTitle': 'Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Safety.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower.', 'orgStudyIdInfo': {'id': 'LACAC_L_04301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Dermacyd PH\\_DETINBACK (Lactic Acid) Sweet Flower', 'interventionNames': ['Drug: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower']}], 'interventions': [{'name': 'Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower', 'type': 'DRUG', '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'}}}}