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Clinical Trials/NL-OMON38649
NL-OMON38649
Completed
Not Applicable

Validation of a questionnaire algorithm for 'allergic contact dermatitis' with the Repeated Open Application Test (ROAT) for fragrances. - Validation of a questionnaire algorithm for 'allergic contact dermatitis'

niversitair Medisch Centrum Groningen0 sites20 target enrollmentTBD
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Conditionsallergic contact dermatitisContact allergy10014982

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
allergic contact dermatitis
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
20
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria for the Fragrance Mix positive subjects:
  • •\- Participated in the EDEN fragrance study and gave permission to be re\-invited for a follow\-up study
  • •\- Positive patch\-test to FM I and/or FM II
  • •\- Adulthood (18 years and older)
  • •\- Legal competent
  • •\- Understands Dutch;Inclusion criteria for the FM\-negative subjects (controls):
  • •\- Participation in the EDEN fragrance study and gave permission to be re\-invited for follow\-up studies
  • •\- Negative patch test results to all fragrances including fragrance mix I and fragrance mix II
  • •\- Matched to the FM\-positive group for age and gender
  • •\- Adulthood (18 years of age or older)

Exclusion Criteria

  • •Exclusion criteria for both groups are:
  • •\- Skin anomalies on the forearms and back such as active eczema
  • •\- Immunosuppressive medication during the study or in the four weeks before inclusion (oral corticosteroids, cyclosporine, methotrexate, azathioprine, biologicals)
  • •\- Pregnancy (wish)
  • •\- Legally incompetent
  • •\- Difficulty understanding oral and written information in Dutch.
  • •\- Angry back in the past (extreme hypersensitivity to pacth test resulting in a red, itching back or multiple false\-positive patch test reactions)

Outcomes

Primary Outcomes

Not specified

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