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

NCT ID: NCT02509403

Last Updated: 2020-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Essential oils infused Perineal Hygiene wipe

Group Type EXPERIMENTAL

Essential oils infused Perineal Hygiene wipe

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taiga BioActives Inc.

INDUSTRY

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian S Wagg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 12113866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22031610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17091423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19469432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5085024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20139217 (View on PubMed)

Other Identifiers

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TAI-WA-0707

Identifier Type: -

Identifier Source: org_study_id

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