NCT00779792

Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation

Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers.

Detailed description

Irritant contact dermatitis (ICD) is a frequent cause of hand eczema and occupational skin disease. One way to study ICD is to expose healthy volunteer skin to chemicals and evaluate the skin response. Because different chemicals act differently on the skin, the use of different skin irritants may provide more information than relying on one irritant only. In this study the two commonly used irritants sodium lauryl sulphate and nonanoic acid are exposed to the skin in a cumulative wash test. Treatment of ICD has classically involved topical steroids and/or emollients. However, the outcome is variable with some patients being very refractory to this regimen. This study was designed to investigate the relative efficacy of the steroids triamcinolone acetonide and clobetasol, the topical immune modulator tacrolimus, a 20% Glycerol ointment compared with an inert ointment vehicle on experimentally induced irritated skin.

Conditions

• Dermatitis, Contact
• Dermatitis, Occupational

Interventions

Type	Name	Description
DRUG	clobetasol	0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days
DRUG	triamcinolone acetonide	0.5 mg ointment twice daily for 10 consecutive days
DRUG	tacrolimus	0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days
DRUG	glycerol	0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days
DRUG	vehicle ointment (paraffin oil/soft white paraffin)	0.5 mg vehicle ointment twice daily for 10 consecutive days

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-10-24
• Last updated: 2008-10-24

Locations

1 site across 1 country: Denmark