Clinical trial NCT00779792: Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation
Official title: Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dermatitis, Contact
Dermatitis, Occupational
Keywords: Irritant contact dermatitis
experimental contact dermatitis
treatment
efficacy
topical steroids
topical immune modulators
glycerol
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: LEO Pharma
name: University of Southern Denmark
First posted: 2008-10-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
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)
timeFrame: End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Dermatology, Odense University Hospital
Study officials:
affiliation: Department of Dermatology, Odense University Hospital
name: Anders Clemmensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jaad.2006.08.063. Epub 2006 Dec 6.
citation: 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.