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

Dermatitis, Contact Clinical Trial

— WA+TR_1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00779792
• Other study ID #: 2008-001678-34
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 23, 2008
• Last updated: October 23, 2008
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Dermatitis, Occupational
• Eczema

Intervention

Drug:
• clobetasol
0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days
• triamcinolone acetonide
0.5 mg ointment twice daily for 10 consecutive days
• tacrolimus
0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days
• glycerol
0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days
• vehicle ointment (paraffin oil/soft white paraffin)
0.5 mg vehicle ointment twice daily for 10 consecutive days

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	LEO Pharma, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No