The EDEN study of the prevalence of fragrance allergy

Aim:
To determine the prevalence and severity of contact dermatitis in the general population in Europe and to assess the rate of sensitisation to fragrances, as documented by standard patch test procedures in the same population. This multinational study involves several areas in four European countries (Sweden, Italy, Germany, The Netherlands). Subsequent phases of the study are planned to include North American and Asia.

Background:
The currently available data is mostly floating numerator data derived from patch test populations with estimates based on patch test reactions as opposed to reactions that are deemed to be clinically relevant and symptomatic. A few epidemiological studies suggest that the point prevalence of contact dermatitis in the general population may vary from 5% to 10% while fragrance sensitization has an expected prevalence of about 1% (Meding B. Acta Dermato-Venereologica 1990; suppl 153:1-43; Nielsen NH, Menné T. Ann Dermatol Venereol 1993;120:33-6).

Methods:
A validated questionnaire is being developed to record demographic aspects, clinical history and product exposure. A stratified sampling design will be adopted to select a representative population sample. To collect data, a face-to-face interview will be performed by trained interviewers in the different areas. A patch test procedure will be offered to the sampled subjects.

Current study design:
This study is currently in the pilot phase. The feasibility of the questionnaire and the patch testing will be examined in a pilot study involving 100 random subjects in each participating center, drawn from the general population registry. This pilot study is planned for late 2006 and early 2007.

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