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

October 23, 2008
October 23, 2008
September 2008
November 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation
Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation

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.

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.

Interventional
Phase 4
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dermatitis, Contact
  • Dermatitis, Occupational
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00779792
2008-001678-34
Yes
Anders Clemmensen, MD, Odense University Hospital
Odense University Hospital
  • LEO Pharma
  • University of Southern Denmark
Principal Investigator: Anders Clemmensen, MD Department of Dermatology, Odense University Hospital
Odense University Hospital
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP