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

University of Alberta

Status and phase: Withdrawn; Phase 1

Conditions: Urinary Tract Infections

Treatments: Drug: Essential oils infused Perineal Hygiene wipe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02509403

TAI-WA-0707

Details and patient eligibility

About

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.

Full description

The design of the trial will be open-label and uncontrolled.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intervention

Experimental group

Description:

Essential oils infused Perineal Hygiene wipe

Treatment:

Drug: Essential oils infused Perineal Hygiene wipe