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

NCT02509403 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-04-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Essential 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 & Collaborators

  • Taiga BioActives Inc.

    collaborator INDUSTRY

  • University of Alberta

    lead OTHER

Principal Investigators

  • Adrian S Wagg, MD · University of Alberta

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02509403 on ClinicalTrials.gov