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Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation

Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dermatitis, Contact; Dermatitis, Occupational

Intervention: clobetasol (Drug); triamcinolone acetonide (Drug); tacrolimus (Drug); glycerol (Drug); vehicle ointment (paraffin oil/soft white paraffin) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Odense University Hospital

Official(s) and/or principal investigator(s):
Anders Clemmensen, MD, Principal Investigator, Affiliation: Department of Dermatology, Odense University Hospital

Summary

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.

Clinical Details

Official title: Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation

Study design: Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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)

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Department of Dermatology, Odense University Hospital, Odense 5000, Denmark
Additional Information

Related publications:

Andersen F, Hedegaard K, Petersen TK, Bindslev-Jensen C, Fullerton A, Andersen KE. Comparison of the effect of glycerol and triamcinolone acetonide on cumulative skin irritation in a randomized trial. J Am Acad Dermatol. 2007 Feb;56(2):228-35. Epub 2006 Dec 6.

Schliemann S, Kelterer D, Bauer A, John SM, Skudlik C, Schindera I, Wehrmann W, Elsner P. Tacrolimus ointment in the treatment of occupationally induced chronic hand dermatitis. Contact Dermatitis. 2008 May;58(5):299-306. doi: 10.1111/j.1600-0536.2007.01314.x.

Starting date: September 2008
Last updated: October 23, 2008

Page last updated: August 23, 2015

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