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Sponsors and Collaborators: |
Odense University Hospital LEO Pharma University of Southern Denmark |
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Information provided by: | Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT00779792 |
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.
Condition | Intervention | Phase |
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Dermatitis, Contact Dermatitis, Occupational |
Drug: clobetasol Drug: triamcinolone acetonide Drug: tacrolimus Drug: glycerol Drug: vehicle ointment (paraffin oil/soft white paraffin) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Double Blind (Subject, Investigator, Outcomes Assessor), Single Group Assignment, Bio-equivalence Study |
Official Title: | Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation |
Enrollment: | 36 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Dermatology, Odense University Hospital | |
Odense, Denmark, 5000 |
Principal Investigator: | Anders Clemmensen, MD | Department of Dermatology, Odense University Hospital |
Responsible Party: | Odense University Hospital ( Anders Clemmensen, MD ) |
Study ID Numbers: | 2008-001678-34 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779792 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency |
Irritant contact dermatitis experimental contact dermatitis treatment efficacy |
topical steroids topical immune modulators glycerol |
Skin Diseases Dermatitis, Occupational Disorders of Environmental Origin Triamcinolone diacetate Tacrolimus Dermatitis, Contact Triamcinolone hexacetonide |
Clobetasol Triamcinolone Acetonide Glycerol Triamcinolone Skin Diseases, Eczematous Occupational Diseases Dermatitis |
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Glucocorticoids |
Hormones Cryoprotective Agents Protective Agents Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses |