NCT00779792

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

October 24, 2008

Status Verified

August 1, 2008

Enrollment Period

2 months

First QC Date

October 23, 2008

Last Update Submit

October 23, 2008

Conditions

Dermatitis, ContactDermatitis, Occupational

Keywords

Irritant contact dermatitisexperimental contact dermatitistreatmentefficacytopical steroidstopical immune modulatorsglycerol

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

clobetasolDRUG

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

Also known as: Dermovate
triamcinolone acetonideDRUG

0.5 mg ointment twice daily for 10 consecutive days

Also known as: Kenalog
tacrolimusDRUG

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

Also known as: Protopic
glycerolDRUG

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

vehicle ointment (paraffin oil/soft white paraffin)DRUG

0.5 mg vehicle ointment twice daily for 10 consecutive days

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • caucasian
  • normal skin on both volar forearms
  • oral and written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Odense University Hospital

Odense, 5000, Denmark

Location

Related 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. doi: 10.1016/j.jaad.2006.08.063. Epub 2006 Dec 6.

    PMID: 17156893BACKGROUND

  • 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.

    PMID: 18416762BACKGROUND

MeSH Terms

Conditions

Dermatitis, ContactDermatitis, OccupationalDermatitis, Irritant

Interventions

ClobetasolTriamcinolone AcetonideTacrolimusGlycerol

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousOccupational Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic CompoundsTriamcinolonePregnadienesPregnanesMacrolidesLactonesOrganic ChemicalsTriose Sugar AlcoholsSugar AlcoholsAlcoholsCarbohydrates

Study Officials

  • Anders Clemmensen, MD

    Department of Dermatology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 24, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

October 24, 2008

Record last verified: 2008-08

Locations

DK(1)