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

Phase 4

• Conditions: Dermatitis, Contact; Dermatitis, Occupational

• Registration Number: NCT00779792
• Lead Sponsor: Odense University Hospital

Brief 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.

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-09
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Last Update Submitted: 2008-10-23
• Study First Posted: 2008-10-24
• Last Update Posted: 2008-10-24
• Primary Completion: 2008-11
• Study Completion: 2008-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• caucasian
• normal skin on both volar forearms
• oral and written informed consent

Exclusion Criteria

• pregnant, lactating women
• no safe anticonceptive method used
• intake of systemic immunosuppressants (e.g. prednisolone)
• endocrine, immune, or liver disorders
• known allergy towards drugs applied to the skin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
level of skin irritation as determined by visual reading, skin redness (color measurement), skin barrier integrity (transepidermal water loss measurement) and skin hydration (capacitance measurement)	End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days

Trial Locations

Locations (1)

Department of Dermatology, Odense University Hospital; 🇩🇰 Odense, Denmark