NCT00133341

Brief Summary

It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile \[MDBGN\], parthenolide) for diagnosing allergic contact dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

February 27, 2006

Status Verified

February 1, 2006

First QC Date

August 22, 2005

Last Update Submit

February 24, 2006

Conditions

Allergic Contact Dermatitis

Keywords

Allergic contact dermatitis,patch testing, dilution series

Outcome Measures

Primary Outcomes (1)

  • Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)

Secondary Outcomes (1)

  • Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])

Interventions

Goldnatriomthiosulphate, MDBGN, parthenolideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive MDBGN patch test within the latest 5 years or positive Parthenolide patch test within the latest 5 years or positive Goldnatriumthiosulphate patch test within the latest 5 years.
  • Age more or equal to 18 years.
  • Signed informed consent.

You may not qualify if:

  • Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
  • Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
  • Treatment with UV-light during the latest 3 weeks.
  • Widespread active dermatitis or dermatitis on test area.
  • Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period.
  • Subjects not able to cooperate.
  • Participation in other clinical studies during the study period and 3 weeks prior to study start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

1,2-dibromo-2,4-dicyanobutaneparthenolide

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Klaus E Andersen, Prof.

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 23, 2005

Study Start

April 1, 2005

Study Completion

December 1, 2005

Last Updated

February 27, 2006

Record last verified: 2006-02

Locations

DK(1)