NCT02309294

14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.

Conditions

• Cumulative Irritation

Interventions

Type	Name	Description
DEVICE	Novel lubricant Miami w/ fragrance	0.2 ml aliquot on occlusive patch
DEVICE	Novel lubricant Miami no fragrance	0.2 ml aliquot on occlusive patch
DEVICE	KY Liquid lubricant	0.2 ml aliquot on occlusive patch
DEVICE	Astroglide Gel lubricant	0.2 ml aliquot on occlusive patch
DEVICE	Wet Platinum lubricant	0.2 ml aliquot on occlusive patch

Timeline

• Start date: 2014-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-12-05
• Last updated: 2016-10-12
• Results posted: 2016-10-12

Locations

1 site across 1 country: United States