NCT04942496

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

A 96 Hour Patch Test Study Using Health Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-06-01
• Completion: 2021-07-01
• First posted: 2021-06-28
• Last updated: 2021-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study