Trial record 13 of 238 for: essential oil

Previous Study | Return to List | Next Study

An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel (WIPEAWAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02509403

Recruitment Status : Suspended (The company responsible for funding has filed for bankruptcy)

First Posted : July 28, 2015

Last Update Posted : September 25, 2019

Sponsor:

Collaborator:

Taiga BioActives Inc.

Information provided by (Responsible Party):

Adrian Wagg, University of Alberta

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Urinary Tract Infections	Drug: Essential oils infused Perineal Hygiene wipe	Phase 1

Detailed Description:

The design of the trial will be open-label and uncontrolled.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
Estimated Study Start Date :	January 2020
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Essential oils infused Perineal Hygiene wipe	Drug: Essential oils infused Perineal Hygiene wipe 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.

Outcome Measures

Primary Outcome Measures :

Number of participants without any adverse events as a measure of safety [ Time Frame: 45 Days ]

Secondary Outcome Measures :

Ease of use of the perineal hygiene wipe by the participants on a daily basis [ Time Frame: 30 Days ]
Self-reported comfort score on a scale of 1 to 10 [ Time Frame: 30 Days ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women aged ≥18 years willing to use the perineal towels for an entire month

Exclusion Criteria:

Pregnancy or within 12 months post-partum
Current vulvo-vaginitis
Known allergies to tea-tree oil

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509403

Locations

Layout table for location information

Canada, Alberta
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, Canada, T6G 2P4

Sponsors and Collaborators

Adrian Wagg

Taiga BioActives Inc.

More Information

Publications:

Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Am J Med. 2002 Jul 8;113 Suppl 1A:5S-13S. Review.

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.

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.

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.

Temple JG. Perineal hygiene in the prevention of recurring cystitis in women. Proc R Soc Med. 1972 Feb;65(2):169.

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.

Layout table for additonal information

Responsible Party:	Adrian Wagg, Research Chair in Healthy Aging, University of Alberta
ClinicalTrials.gov Identifier:	NCT02509403 History of Changes
Other Study ID Numbers:	TAI-WA-0707
First Posted:	July 28, 2015 Key Record Dates
Last Update Posted:	September 25, 2019
Last Verified:	September 2019

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Adrian Wagg, University of Alberta:


Perineal hygiene Hygiene wipes Hygiene Towels	Safety Essential oils Natural Health Product

Additional relevant MeSH terms:

Layout table for MeSH terms

Urinary Tract Infections Infection Urologic Diseases

To Top