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Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation (WA+TR_1)

Primary Purpose

Dermatitis, Contact, Dermatitis, Occupational

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
clobetasol
triamcinolone acetonide
tacrolimus
glycerol
vehicle ointment (paraffin oil/soft white paraffin)
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Contact focused on measuring Irritant contact dermatitis, experimental contact dermatitis, treatment, efficacy, topical steroids, topical immune modulators, glycerol

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Dermatology, Odense University Hospital

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 23, 2008
Last Updated
October 23, 2008
Sponsor
Odense University Hospital
Collaborators
LEO Pharma, University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00779792
Brief Title
Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation
Acronym
WA+TR_1
Official Title
Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital
Collaborators
LEO Pharma, University of Southern Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Contact, Dermatitis, Occupational
Keywords
Irritant contact dermatitis, experimental contact dermatitis, treatment, efficacy, topical steroids, topical immune modulators, glycerol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
clobetasol
Other Intervention Name(s)
Dermovate
Intervention Description
0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Other Intervention Name(s)
Kenalog
Intervention Description
0.5 mg ointment twice daily for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Protopic
Intervention Description
0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
glycerol
Intervention Description
0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
vehicle ointment (paraffin oil/soft white paraffin)
Intervention Description
0.5 mg vehicle ointment twice daily for 10 consecutive days
Primary Outcome Measure Information:
Title
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)
Time Frame
End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Clemmensen, MD
Organizational Affiliation
Department of Dermatology, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
17156893
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.
Results Reference
background
PubMed Identifier
18416762
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.
Results Reference
background

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

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