Trial | NCT02509403  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    essential oils ...

  • Study Participants

    0
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.
The design of the trial will be open-label and uncontrolled.
Study Started
Jan 31
2020
Anticipated
Primary Completion
Jan 31
2020
Anticipated
Study Completion
Jan 31
2020
Anticipated
Last Update
Apr 01
2020

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.

Intervention Experimental

Essential oils infused Perineal Hygiene wipe

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
No Results Posted