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

Completed

Conditions: allergic contact dermatitis
Contact allergy
10014982

Registration Number: NL-OMON38649

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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)
- Legal competence
- Understands Dutch

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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study result is the level of agreement between the result of the<br /><br>ROAT and the questionnaire algorithm (combination of patch test result and<br /><br>questionnaire), both defined as a dichotomous variable: POSITIVE or NEGATIVE<br /><br><br /><br>Minimal criteria for a positive ROAT are the presence of erythema and<br /><br>infiltration in the same area and possibly papules and vesicles in affected<br /><br>area and covering at least 25% of the area of application.</p><br>

Secondary Outcome Measures