WithdrawnPhase 1

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

Stopped: The company responsible for funding has filed for bankruptcy

Canada0Started 2020-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants without any adverse events as a measure of safety

Timeframe: 45 Days

Trial details

NCT IDNCT02509403

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01

View on ClinicalTrials.gov More Urinary Tract Infections trials