NCT01762982

Patch Test of Benzalkonium Chloride Disinfectant Spray

A Single Centre, Examiner-blind Human Patch Test of Bactroban Disinfectant Liquid on Normal Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.

Detailed description

Benzalkonium chloride is recognized as safe and effective for short term use as first aid antiseptic drug products. In this study, benzalkonium chloride disinfectant spray will be compared to a positive control, and two negative control for irritancy potential on normal skin according to Chinese Patch Test Guideline (China Health Authority 2002). The skin irritation assessment will characterize the test products individually in terms of symptomatology using a 5-point categorical scale ranging from 0 (no visible reaction) to 4 (Erythema,edema˛ extreme blistering).

Conditions

• Wound Healing

Interventions

Type	Name	Description
DRUG	0.13% Benzalkonium Chloride	Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution
DRUG	SLS Solution	Finn Chamber filled with SLS (0.3% w/v) water solution
DRUG	Normal Saline Water	Finn Chamber filled with Normal Saline water (0.9% w/v)
OTHER	Empty Finn Chamber	Empty Finn Chamber

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2013-01-08
• Last updated: 2014-01-22
• Results posted: 2014-01-22

Locations

1 site across 1 country: China