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Validation of questionnaire algorithm based on repeated open application testing (ROAT) with the constituents of fragrance mix II: The EDEN Fragrance Study

J Eur Acad Dermatol Venereol. 2021 Apr 29. doi: 10.1111/jdv.17315. Online ahead of print.

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 ROAT and the patch test reactivity.

METHODS: 109 subjects with and without contact allergy to fragrance mix II (FM II) were recruited. Volunteers from 6 European dermatology clinics participated in the study including a patch test and a ROAT.

RESULTS: 24 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.

PMID:33914959 | DOI:10.1111/jdv.17315

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