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 because the information has not been verified recently.
Verified August 2008 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
LEO Pharma
University of Southern Denmark
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00779792
First received: October 23, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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

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 ] [ 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
    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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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
Occupational Diseases
Skin Diseases
Skin Diseases, Eczematous
Clobetasol
Glycerol
Immunologic Factors
Tacrolimus
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Cryoprotective Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014