MedTrace Logo

A 96-hour Patch Test Study Using Healthy Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations

NCT04942496 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-06-28

No results posted yet for this study

Summary

This study is an evaluation of the irritation potential of 9 test products and 2 control materials applied to the backs of at least 44 volunteer human subjects over the course of a 96-hour period to determine and compare irritation scores. Subjects will be required to complete a 7-day pre-test conditioning period prior to the test period. Finn Chambers® on Scanpor® will be used to apply each test material to a designated site on the skin of the parascapular region of the upper back every 24 hours for 96 hours. The sites will be evaluated visually prior to the first patch application and immediately following each patch removal. Instrument measurements of transepidermal water loss (TEWL) will also be performed prior to the first patch application and will start between 15 to 30 minutes, following removal of each patch.

Conditions

  • Skin Irritancy Potential

Interventions

DRUG

Chlorhexidine Gluconate

Antimicrobial Skin Wash

DEVICE

Hibi Universal Bathing System

Cloths used for patient bathing

OTHER

0.1% SLS

Positive control

OTHER

Distilled Water

Negative Control

Sponsors & Collaborators

  • BioScience Laboratories, Inc.

    collaborator INDUSTRY

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Kendra Drake · BSLI

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-06-30
Completion
2021-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04942496 on ClinicalTrials.gov