An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel
Phase 1
Withdrawn
- Conditions
- Urinary Tract Infections
- Interventions
- Drug: Essential oils infused Perineal Hygiene wipe
- Registration Number
- NCT02509403
- Lead Sponsor
- University of Alberta
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Women aged ≥18 years willing to use the perineal towels for an entire month
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Exclusion Criteria
- Pregnancy or within 12 months post-partum
- Current vulvo-vaginitis
- Known allergies to tea-tree oil
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Essential oils infused Perineal Hygiene wipe Essential oils infused Perineal Hygiene wipe
- Primary Outcome Measures
Name Time Method Number of participants without any adverse events as a measure of safety 45 Days Number of participants without any adverse events
- Secondary Outcome Measures
Name Time Method Self-reported comfort score on a scale of 1 to 10 30 Days Self-reported comfort score on a scale of 1 to 10
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
Trial Locations
- Locations (1)
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
🇨🇦Edmonton, Alberta, Canada