Patch testing with a new fragrance mix detects additional patients sensitive to perfumes and missed by the current fragrance mix

Abstract

The currently used 8% fragrance mix (FM I) does not identify all patients with a positive history of adverse reactions to fragrances. A new FM II with 6 frequently used chemicals was evaluated in 1701 consecutive patients patch tested in 6 dermatological centres in Europe. FM II was tested in 3 concentrations - 28% FM II contained 5% hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral), 2% citral, 5% farnesol, 5% coumarin, 1% citronellol and 10%alpha-hexyl-cinnamic aldehyde; in 14% FM II, the single constituents' concentration was lowered to 50% and in 2.8% FM II to 10%. Each patient was classified regarding a history of adverse reactions to fragrances: certain, probable, questionable, none. Positive reactions to FM I occurred in 6.5% of the patients. Positive reactions to FM II were dose-dependent and increased from 1.3% (2.8% FM II), through 2.9% (14% FM II) to 4.1% (28% FM II). Reactions classified as doubtful or irritant varied considerably between the 6 centres, with a mean value of 7.2% for FM I and means ranging from 1.8% to 10.6% for FM II. 8.7% of the tested patients had a certain fragrance history. Of these, 25.2% were positive to FM I; reactivity to FM II was again dose-dependent and ranged from 8.1% to 17.6% in this subgroup. Comparing 2 groups of history - certain and none - values for sensitivity and specificity were calculated: sensitivity: FM I, 25.2%; 2.8% FM II, 8.1%; 14% FM II, 13.5%; 28% FM II, 17.6%; specificity: FM I, 96.5%; 2.8% FM II, 99.5%; 14% FM II, 98.8%; 28% FM II, 98.1%. 31/70 patients (44.3%) positive to 28% FM II were negative to FM I, with 14% FM II this proportion being 16/50 (32%). In the group of patients with a certain history, a total of 7 patients were found reacting to FM II only. Conversely, in the group of patients without any fragrance history, there were significantly more positive reactions to FM I than to any concentration of FM II. In conclusion, the new FM II detects additional patients sensitive to fragrances missed by FM I; the number of false-positive reactions is lower with FM II than with FM I. Considering sensitivity, specificity and the frequency of doubtful reactions, the medium concentration, 14% FM II, seems to be the most appropriate diagnostic screening tool.

Design and Feasibility of an International Study Assessing the Prevalence of Contact Allergy to Fragrances in the General Population: The European Dermato-Epidemiology Network Fragrance Study

“…In fact, to our knowledge, no previous studies have investigated the prevalence of fragrance mix 2 sensitization in the general population. The frequency of contact sensitization to fragrances strictly depends on the number of allergens tested, and patch testing with fragrance mix 2 detects additional patients sensitive to perfumes and missed by fragrance mix 1 testing [7,12,13]; thus, we would expect that the overall prevalence of contact sensitization to fragrances would be higher than prevalence estimates so far. This inclusion could account, at least in part, for the relatively high frequency of contact sensitization to fragrances we found in the pilot investigation.…”

Reactividad y evolución de 4.022 tests de parche en dermatitis de contacto realizadas entre 1995 y 2011 en Santiago de Chile

“…Para estudiar esta reactividad anual y evolutiva seleccionamos 3 alérgenos; níquel, mezcla de fragancias (por ser los más importantes en mujeres y hombres respectivamente) y p-fenilenediamina, porque su inclusión en la batería estándar ha sido materia de amplia discusión recientemente 20,21 .…”

“…Esto podría explicarse por recientes sustituciones de algunos alérgenos en las nuevas formulaciones cosméticas. Lo anterior también confirma la necesidad de incorporar una nueva batería de alérgenos para fragancias (MF II) a nuestras baterías estándar, como se ha hecho en otros lugares del mundo 20,21 . figura 3.…”

Allergic contact dermatitis to a perfume containing lyral

“…1 Studies performed in Europe and in the United States have clearly demonstrated that adding lyral or fragrance mix II to patch test panels used for patients with suspected fragrance allergy will identify some individuals with fragrance allergy who are not diagnosed with the standard fragrance allergens. 2,3 The European study found that 4% of patients reacted to fragrance mix II and that nearly half of these patients did not react to the standard fragrance mix. 2 The US study found that 0.4% of patients reacted to lyral.…”