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Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation (WA+TR_1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
LEO Pharma
University of Southern Denmark
Information provided by:
Odense University Hospital Identifier:
First received: October 23, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
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: Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, 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

Resource links provided by NLM:

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 ]

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
    Other Name: Dermovate
    Drug: triamcinolone acetonide
    0.5 mg ointment twice daily for 10 consecutive days
    Other Name: Kenalog
    Drug: tacrolimus
    0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days
    Other Name: Protopic
    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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00779792

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

Responsible Party: Anders Clemmensen, MD, Odense University Hospital Identifier: NCT00779792     History of Changes
Other Study ID Numbers: 2008-001678-34
Study First Received: October 23, 2008
Last Updated: October 23, 2008

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

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Occupational
Skin Diseases
Skin Diseases, Eczematous
Occupational Diseases
Triamcinolone Acetonide
Triamcinolone diacetate
Immunologic Factors
Triamcinolone hexacetonide
Immunosuppressive Agents
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Cryoprotective Agents
Protective Agents processed this record on May 25, 2017