Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation (WA+TR_1)
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Dermatitis, Contact Dermatitis, Occupational |
Drug: clobetasol Drug: triamcinolone acetonide Drug: tacrolimus Drug: glycerol Drug: vehicle ointment (paraffin oil/soft white paraffin) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation |
- 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 ] [ Designated as safety issue: No ]
| 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) |
-
Drug: clobetasol
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Denmark | |
| Department of Dermatology, Odense University Hospital | |
| Odense, Denmark, 5000 | |
| Principal Investigator: | Anders Clemmensen, MD | Department of Dermatology, Odense University Hospital |
More Information
Publications:
| Responsible Party: | Anders Clemmensen, MD, Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT00779792 History of Changes |
| Other Study ID Numbers: | 2008-001678-34 |
| Study First Received: | October 23, 2008 |
| Last Updated: | October 23, 2008 |
| Health Authority: | Denmark: Danish Medicines Agency Denmark: Ethics Committee Denmark: Danish Dataprotection Agency |
Keywords provided by Odense University Hospital:
|
Irritant contact dermatitis experimental contact dermatitis treatment efficacy |
topical steroids topical immune modulators glycerol |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Contact Dermatitis, Occupational Skin Diseases Skin Diseases, Eczematous Occupational Diseases Immunologic Factors Triamcinolone Acetonide Tacrolimus Triamcinolone hexacetonide Clobetasol Triamcinolone Glycerol |
Triamcinolone diacetate Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Cryoprotective Agents Protective Agents Immunosuppressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013