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Trial record 13 of 238 for:    essential oil

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

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.

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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

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.




Primary Outcome Measures :
  1. Number of participants without any adverse events as a measure of safety [ Time Frame: 45 Days ]

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


Information from the National Library of Medicine

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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

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
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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.

Publications:
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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

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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:
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Urinary Tract Infections
Infection
Urologic Diseases