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

Study Overview
=================
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.

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

Conditions
-----------------
Dermatitis, Contact, Dermatitis, Occupational

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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: clobetasol|0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days|
|Drug: triamcinolone acetonide|0.5 mg ointment twice daily for 10 consecutive days|
|Drug: tacrolimus|0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days|
|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|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritant contact dermatitis, experimental contact dermatitis, treatment, efficacy, topical steroids, topical immune modulators, glycerol