Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-29 @ 10:36 PM
Study NCT ID:
NCT00784056
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2008-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Photo Evaluation
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': '2008-10-31', '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 photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.', 'timeFrame': 'Throughout the study'}, {'measure': '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 PHDETINLYN 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 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 immunossupression 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 photo induced 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;'}, 'identificationModule': {'nctId': 'NCT00784056', 'briefTitle': 'Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Photo Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)', 'orgStudyIdInfo': {'id': 'LACAC_L_04306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lactic Acid (Dermacyd PH\\_DETINLYN Tangerine Mix)', 'interventionNames': ['Drug: Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)']}], 'interventions': [{'name': 'Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)', 'type': 'DRUG', 'description': 'Lactic Acid (Dermacyd PH\\_DETINLYN Tangerine Mix)', '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'}}}}