Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT02509403
Status:
WITHDRAWN
Last Update Posted:
2020-04-01
First Post:
2015-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The company responsible for funding has filed for bankruptcy', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2015-07-24', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants without any adverse events as a measure of safety', 'timeFrame': '45 Days', 'description': 'Number of participants without any adverse events'}], 'secondaryOutcomes': [{'measure': 'Ease of use of the perineal hygiene wipe by the participants on a daily basis', 'timeFrame': '30 Days', 'description': 'Ease of use of the perineal hygiene wipe by the participants on a daily basis'}, {'measure': 'Self-reported comfort score on a scale of 1 to 10', 'timeFrame': '30 Days', 'description': 'Self-reported comfort score on a scale of 1 to 10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perineal hygiene', 'Hygiene wipes', 'Hygiene Towels', 'Safety', 'Essential oils', 'Natural Health Product'], 'conditions': ['Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '12113866', 'type': 'BACKGROUND', 'citation': 'Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Am J Med. 2002 Jul 8;113 Suppl 1A:5S-13S. doi: 10.1016/s0002-9343(02)01054-9.'}, {'pmid': '22031610', 'type': 'BACKGROUND', 'citation': 'Dason S, Dason JT, Kapoor A. Guidelines for the diagnosis and management of recurrent urinary tract infection in women. Can Urol Assoc J. 2011 Oct;5(5):316-22. doi: 10.5489/cuaj.11214. No abstract available.'}, {'pmid': '17091423', 'type': 'BACKGROUND', 'citation': 'Persad S, Watermeyer S, Griffiths A, Cherian B, Evans J. Association between urinary tract infection and postmicturition wiping habit. Acta Obstet Gynecol Scand. 2006;85(11):1395-6. doi: 10.1080/00016340600936977.'}, {'pmid': '19469432', 'type': 'BACKGROUND', 'citation': 'Amiri FN, Rooshan MH, Ahmady MH, Soliamani MJ. Hygiene practices and sexual activity associated with urinary tract infection in pregnant women. East Mediterr Health J. 2009 Jan-Feb;15(1):104-10.'}, {'pmid': '5085024', 'type': 'BACKGROUND', 'citation': 'Temple JG. Perineal hygiene in the prevention of recurring cystitis in women. Proc R Soc Med. 1972 Feb;65(2):169. doi: 10.1177/003591577206500222. No abstract available.'}, {'pmid': '20139217', 'type': 'BACKGROUND', 'citation': "Leydon GM, Turner S, Smith H, Little P; UTIS team. Women's views about management and cause of urinary tract infection: qualitative interview study. BMJ. 2010 Feb 5;340:c279. doi: 10.1136/bmj.c279."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety (absence of skin irritation) of a feminine hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. The feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.', 'detailedDescription': 'The design of the trial will be open-label and uncontrolled.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged ≥18 years willing to use the perineal towels for an entire month\n\nExclusion Criteria:\n\n* Pregnancy or within 12 months post-partum\n* Current vulvo-vaginitis\n* Known allergies to tea-tree oil'}, 'identificationModule': {'nctId': 'NCT02509403', 'acronym': 'WIPEAWAY', 'briefTitle': 'An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY', 'orgStudyIdInfo': {'id': 'TAI-WA-0707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Essential oils infused Perineal Hygiene wipe', 'interventionNames': ['Drug: Essential oils infused Perineal Hygiene wipe']}], 'interventions': [{'name': 'Essential oils infused Perineal Hygiene wipe', 'type': 'DRUG', 'description': "Each participant will be asked to complete a treatment period of one month's duration. At the start of the study, the participants will be asked to fill-out a baseline questionnaire and will be given a month's supply of the perineal hygiene towel with instructions about its use. At day 15, 30 and 45 follow-ups will be conducted.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2P4', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Adrian S Wagg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taiga BioActives Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}