allergic contact dermatitis Contact allergy
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion 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) - Legal competence - Understands Dutch
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study result is the level of agreement between the result of the ROAT and the questionnaire algorithm (combination of patch test result and questionnaire), both defined as a dichotomous variable: POSITIVE or NEGATIVE Minimal criteria for a positive ROAT are the presence of erythema and infiltration in the same area and possibly papules and vesicles in affected area and covering at least 25% of the area of application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other parameters are: - The result of the patch test: The presence or absence of a positive reaction at day 3 or day 7 at the skin site where the patch has been applied. Reading of the reaction will be according to the criteria of the ICDRG, whereby 'positive' includes a + , a ++ or a +++ reading. - The result of the ROAT whereby the minimal criteria for a positive ROAT are the presence of erythema and infiltration in the same area and possibly papules and vesicles in affected area and covering at least 25% of the area of application. - Negative - Doubtful Erythema and/or infiltration/papules/vesicles not fulfilling the minimal criteria for a positive reaction. - Weakly pos 25-50% coverage with erythema and infiltration in the same area and possibly papules and few vesicles - Moderately positive > 50% coverage with erythema and infiltration in the same area and possibly papules and few vesicles - Strongly positive > 50% coverage with erythema and infiltration in the same area and possibly papules and at lest 10-25 vesicles - the result of the algorithm of the questionnaire - combination of the above mentoined factors. | — |
Countries
Netherlands
Outcome results
None listed