Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation
This trial is active, not recruiting.
|Conditions||dermatitis, contact, dermatitis, occupational|
|Treatments||clobetasol, triamcinolone acetonide, tacrolimus, glycerol, vehicle ointment (paraffin oil/soft white paraffin)|
|Sponsor||Odense University Hospital|
|Start date||September 2008|
|End date||November 2008|
|Trial size||36 participants|
|Trial identifier||NCT00779792, 2008-001678-34|
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.
|Endpoint classification||bio-equivalence study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
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
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
|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.|
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