Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-06 @ 4:11 PM
Study NCT ID:
NCT00397527
Status:
COMPLETED
Last Update Posted:
2008-05-16
First Post:
2006-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability Dermacyd Wipes - Lactoserum - Hygiene
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C018577', 'term': 'lactoserum'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2008-05-15', 'studyFirstSubmitDate': '2006-11-08', 'studyFirstSubmitQcDate': '2006-11-08', 'lastUpdatePostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events and their association with the treatment.'}]}, 'conditionsModule': {'conditions': ['Hygiene']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.\n\nMain criteria are listed hereafter:\n\nInclusion Criteria:\n\n* Integral skin in the tested region\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding women;\n* Use of antiinflammatory or immunosuppression drugs;\n* Topical medication use at the region to be treated;\n* Cutaneous disease or active gynaecological disease which may interfer in study results;\n* Personal history of allergic disease at the area to be treated;\n* Allergic or atopic history.'}, 'identificationModule': {'nctId': 'NCT00397527', 'briefTitle': 'Acceptability Dermacyd Wipes - Lactoserum - Hygiene', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety Dermatological Evaluation: Acceptability With Gynecological Follow up of Dermacyd Wipes', 'orgStudyIdInfo': {'id': 'LACTO_L_01810'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lactoserum', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Jaderson Lima', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}