Overview

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

Status:
Withdrawn
Trial end date:
2020-01-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Adrian Wagg
University of Alberta
Collaborator:
Taiga BioActives Inc.
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