Validation of questionnaire algorithm based on repeated open application testing with the constituents of fragrance mix II: the EDEN Fragrance Study. (16th May 2021)

• Record Type: Journal Article
• Authors: Bruze, M.; Engfeldt, M.; Elsner, P.; Gonçalo, M.; Naldi, L.; Schuttelaar, M.L.A.; Svedman, C.; Svensson, Å.; Ofenloch, R.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 35:Number 8(2021)
• Page Start: 1692
• Page End: 1701
• Publication Date: 2021-05-16
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.17315
• Languages: English
• ISSNs: 0926-9959

Abstract

Abstract: Background: In a European study on contact allergy in the general population, it has been hypothesized that the combination of contact allergy to a fragrance together with a history indicating dermatitis at exposure and thereafter subsequent avoidance of scented products implied a diagnosis of allergic contact dermatitis. Objectives: The primary aim of this study was to validate this hypothesis/algorithm. The secondary aim was to investigate whether there was any association between the outcome of the recent repeated open application test (ROAT) and the patch test reactivity. Methods: One hundred nine subjects with and without contact allergy to fragrance mix II (FM II) were recruited. Volunteers from six European dermatology clinics participated in the study including a patch test and a ROAT. Results: Twenty‐four positive ROAT reactions were noted in total including 20 of those 32 with contact allergy to FM II. None of the volunteers reacted to the vehicle ( P < 0.001). More individuals with a positive algorithm had positive ROATs when compared with those with a negative algorithm. However, the difference was not statistically significant ( P = 0.12). The lower the patch test concentration eliciting a positive test reaction, the more likely was a positive ROAT and the more likely that the positive ROAT appeared early during the investigative period. Conclusions: The algorithm used in this study was not validated but it was indicated in this ROAT setup. The stronger the patch test reactivity the more likely was a positive ROAT and the more likely it was that the positive ROAT appeared early during the application period.