Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-28 @ 10:57 PM
Study NCT ID:
NCT00784160
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2008-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- 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': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-21', 'studyFirstSubmitDate': '2008-10-31', 'studyFirstSubmitQcDate': '2008-10-31', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', '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']}, '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 PHDETINBACK Tangerine Mix (Lactic Acid).'}, '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* 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;'}, 'identificationModule': {'nctId': 'NCT00784160', 'briefTitle': 'Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.', 'orgStudyIdInfo': {'id': 'LACAC_L_04308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lactic Acid', 'interventionNames': ['Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)']}], 'interventions': [{'name': 'Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)', 'type': 'DRUG', 'description': 'Lactic Acid', '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'}}}}