Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT00933257
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2009-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal
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': 27}}, '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': 'Measure of the photo irritation test and the photosensitivity byusing UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.', 'timeFrame': 'From the treatment start to the end of the study (treatment period 5 weeks)'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd PHDESILSTYFR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Phototype Skin II and III 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 until 3 months before volunteers selection\n* Disease which can cause immunosuppresion, such as diabetes, HIV\n* Concomitant use of photosensitivity drugs\n* History of sensitivity or photosensitivity with topic products\n* Cutaneous active disease which can modify the study results\n* History or activity of photodermatosis\n* Personal or family antecedents of cutaneous neoplasia photo induced\n* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis\n* Intense exposure solar in the test region\n* Use of new drugs and/or cosmetics during the study\n* Previous participation in studies using the same product in test\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': 'NCT00933257', 'briefTitle': 'Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Study Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DESILSTY_FR.', 'orgStudyIdInfo': {'id': 'LACAC_L_04808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dermacyd PH_DESILSTY_FR (Lactic Acid)', 'description': 'Dermacyd PH\\_DESILSTY\\_FR (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 5 weeks', 'armGroupLabels': ['Dermacyd PH_DESILSTY_FR (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'}}}}