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Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation (WA+TR_1)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Odense University Hospital
LEO Pharma
University of Southern Denmark
Information provided by: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00779792
  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 IV

Drug Information available for: Tacrolimus Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide Tacrolimus anhydrous Glycerol Clobetasol Clobetasol propionate Paraffin
U.S. FDA Resources
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

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Drug: clobetasol
    0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days
    Drug: triamcinolone acetonide
    0.5 mg ointment twice daily for 10 consecutive days
    Drug: tacrolimus
    0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days
    Drug: glycerol
    0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days
    Drug: vehicle ointment (paraffin oil/soft white paraffin)
    0.5 mg vehicle ointment twice daily for 10 consecutive days
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779792

Locations
Denmark
Department of Dermatology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
LEO Pharma
University of Southern Denmark
Investigators
Principal Investigator: Anders Clemmensen, MD Department of Dermatology, Odense University Hospital
  More Information

Publications:
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

Keywords provided by Odense University Hospital:
Irritant contact dermatitis
experimental contact dermatitis
treatment
efficacy
topical steroids
topical immune modulators
glycerol

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009