Urinary Tract Infections
Conditions
Keywords
Perineal hygiene, Hygiene wipes, Hygiene Towels, Safety, Essential oils, Natural Health Product
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.
Interventions
DRUGEssential 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.
Sponsors
Taiga BioActives Inc.
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants without any adverse events as a measure of safety | 45 Days | Number of participants without any adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use of the perineal hygiene wipe by the participants on a daily basis | 30 Days | Ease of use of the perineal hygiene wipe by the participants on a daily basis |
| Self-reported comfort score on a scale of 1 to 10 | 30 Days | Self-reported comfort score on a scale of 1 to 10 |
Countries
Canada
Outcome results
None listed