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Trial record 13 of 245 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

Tracking Information
First Submitted Date  ICMJE July 24, 2015
First Posted Date  ICMJE July 28, 2015
Last Update Posted Date September 25, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
Number of participants without any adverse events as a measure of safety [ Time Frame: 45 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02509403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel
Official Title  ICMJE An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
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.
Detailed Description The design of the trial will be open-label and uncontrolled.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Urinary Tract Infections
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Intervention
Essential oils infused Perineal Hygiene wipe
Intervention: Drug: Essential oils infused Perineal Hygiene wipe
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: July 24, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02509403
Other Study ID Numbers  ICMJE TAI-WA-0707
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adrian Wagg, University of Alberta
Study Sponsor  ICMJE Adrian Wagg
Collaborators  ICMJE Taiga BioActives Inc.
Investigators  ICMJE Not Provided
PRS Account University of Alberta
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP