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

NCT ID: NCT00779792

Last Updated: 2008-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Dermatitis, Contact Dermatitis, Occupational

Keywords

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Irritant contact dermatitis experimental contact dermatitis treatment efficacy topical steroids topical immune modulators glycerol

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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clobetasol

0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days

Intervention Type DRUG

triamcinolone acetonide

0.5 mg ointment twice daily for 10 consecutive days

Intervention Type DRUG

tacrolimus

0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days

Intervention Type DRUG

glycerol

0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days

Intervention Type DRUG

vehicle ointment (paraffin oil/soft white paraffin)

0.5 mg vehicle ointment twice daily for 10 consecutive days

Intervention Type DRUG

Other Intervention Names

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Dermovate Kenalog Protopic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Odense University Hospital

Principal Investigators

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Anders Clemmensen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Odense University Hospital

Locations

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Department of Dermatology, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 17156893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18416762 (View on PubMed)

Other Identifiers

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2008-001678-34

Identifier Type: -

Identifier Source: org_study_id