Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00785720
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2008-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation
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': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-21', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.', 'timeFrame': 'Throughout the study'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Phototype Skin II and III;\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 15 days before the selection;\n* Diseases which can cause immunity decrease, such as HIV, diabetes;\n* Use of drug photosensitizer;\n* History of sensitivity or irritation for topic products;\n* Active cutaneous disease which can change the study results;\n* History of photodermatosis active;\n* Family or personal antecedent of cutaneous photoinduced neoplasias;\n* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;\n* Intense solar exposure in the study area;\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': 'NCT00785720', 'briefTitle': 'Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower', 'orgStudyIdInfo': {'id': 'LACAC_L_04303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Dermacyd PH\\_DETINBACK (Lactic Acid)', 'interventionNames': ['Drug: Dermacyd PH_DETINBACK (Lactic Acid)']}], 'interventions': [{'name': 'Dermacyd PH_DETINBACK (Lactic Acid)', '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'}}}}