Overview

This trial is active, not recruiting.

Conditions dermatitis, contact, dermatitis, occupational
Treatments clobetasol, triamcinolone acetonide, tacrolimus, glycerol, vehicle ointment (paraffin oil/soft white paraffin)
Phase phase 4
Sponsor Odense University Hospital
Collaborator LEO Pharma
Start date September 2008
End date November 2008
Trial size 36 participants
Trial identifier NCT00779792, 2008-001678-34

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-equivalence study
Intervention model single group assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment

Primary Outcomes

Measure
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)
time frame: End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation
Principal investigator Anders Clemmensen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by Odense University Hospital.