NCT02224625

Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Detailed description

For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day. The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.

Conditions

• Surgery

Interventions

Type	Name	Description
DRUG	2% CHG Cloth solution	Investigational CHG
DEVICE	Vehicle Cloth	Excipients from CHG cloth only
DRUG	Active Comparator	Active comparator
OTHER	Saline	Negative control
OTHER	SLS	Provides a slight irritation for a positive control

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-08-25
• Last updated: 2017-03-09
• Results posted: 2016-05-30

Locations

1 site across 1 country: United States