NCT02509403

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2015-07-28
• Last updated: 2020-04-01

Locations

1 site across 1 country: Canada