Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT00933569
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2009-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dermacyd Silver Floral (Lactic Acid) - Acceptability.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-13', 'studyFirstSubmitDate': '2009-07-03', 'studyFirstSubmitQcDate': '2009-07-03', 'lastUpdatePostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.', 'timeFrame': 'From the treatment start to the end of the study (treatment period 21 days)'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo prove the safety of the gynaecological formulation in normal conditions of use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Integral vaginal mucosa in the product analysis region\n* Use the same category of cosmetics products\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* Use of Anti-inflammatory, immunossupression or antihistaminics drugs\n* Allergic or atopic history to cosmetics products\n* Cutaneous active disease (local and/or general) in the evaluated area\n* Disease which can cause immunosuppresion, such as diabetes, HIV\n* Endocrinology pathology such as thyroid gland, ovary and adrenal gland\n* Intensive solar exposure until 15 days before evaluation\n* Gynecological treatment until four weeks before the study\n* Other reason considered by the investigator as a reason for not being included.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00933569', 'briefTitle': 'Dermacyd Silver Floral (Lactic Acid) - Acceptability.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).', 'orgStudyIdInfo': {'id': 'LACAC_L_04838'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dermacyd Silver Floral (Lactic Acid)', 'description': 'Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days', 'interventionNames': ['Drug: LACTIC ACID(ND)']}], 'interventions': [{'name': 'LACTIC ACID(ND)', 'type': 'DRUG', 'description': 'treatment period: 21 consecutive days', 'armGroupLabels': ['Dermacyd Silver Floral (Lactic Acid)']}]}, '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'}}}}