Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00933504
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) - Compatibility - Stay on Floral
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, '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 primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale', 'timeFrame': 'from the treatment start to the end of the study (treatment duration 6 weeks)'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Phototype Skin I,II, III e IV 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 pregnancy\n* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection\n* Disease which can cause immunosuppresion, such as diabetes, HIV\n* Use of Antihistamines 30 days before selection\n* Personnel history of atopy\n* History of sensitivity or irritation for topic products\n* Cutaneous active disease (local and/or general) which can modify the study results\n* Use of new drugs and/or cosmetics during the study\n* Cutaneous reactive\n* Previous participation in studies using the same product in test\n* Volunteer which has immunodeficiency congenital or acquired\n* Relevant history or confirmation of alcohol or other drugs abuse\n* Intolerance detected or suspected for some component of the sample tested\n* Medecin or sponsor employees or their close family\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00933504', 'briefTitle': 'Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd PH_DESILSTY_FL (Lactic Acid).', 'orgStudyIdInfo': {'id': 'LACAC_L_04804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dermacyd Silver Floral (Lactic Acid)', 'description': 'Lactic Acid sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample', 'interventionNames': ['Drug: LACTIC ACID(ND)']}], 'interventions': [{'name': 'LACTIC ACID(ND)', 'type': 'DRUG', 'description': 'Treatment duration: 6 weeks.', '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'}}}}