Can the reporting of adverse skin reactions to cosmetics be improved? A prospective clinical study using a structured protocol.
BACKGROUND
The use of cosmetics is rising, and adverse reactions to these products are increasing. In Sweden, the Medical Products Agency (MPA) keeps a voluntary reporting system for such adverse reactions. However, the reporting is sparse, consisting almost only of cases with test-proven allergic contact dermatitis, thus under-reporting the more common irritant reactions.


OBJECTIVE
The aim of the study was to try to improve the reporting system.


METHODS
Dermatologists at 3 dermatology departments used a structured protocol during the clinical investigation of 151 consecutive patients reporting skin reactions to cosmetics. The protocol included symptoms, signs, affected body site, suspected products, and final diagnosis after patch testing. Based on clinical data and patch test results, a causality assessment for each product was made according to a protocol used at the MPA.


RESULTS
Allergic contact dermatitis was found in 28% of the patients, and irritant reactions were equally common at 27%.


CONCLUSIONS
Using this structured protocol, the cases of irritant dermatitis were also reported, and it is recommended that such a protocol is used as a standard to improve the reporting of adverse reactions to skin care products.
Berne
Berit
B
Department of Medical Sciences, Section of Dermatology and Venereology, University Hospital, S-751 85 Uppsala, Sweden. berit.berne@medsci.uu.se
Tammela
Monica
M
Färm
Gunilla
G
Inerot
Annica
A
Lindberg
Magnus
M
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards* / Q000706:statistics & numerical data; D000368:Aged; D000369:Aged, 80 and over; D015984:Causality; D002648:Child; D002985:Clinical Protocols; D003358:Cosmetics / Q000009:adverse effects*; D003872:Dermatitis / Q000175:diagnosis; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis / Q000209:etiology*; D017453:Dermatitis, Irritant / Q000175:diagnosis / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010328:Patch Tests; D011446:Prospective Studies; D018570:Risk Assessment / Q000379:methods; D012867:Skin / Q000473:pathology; D018709:Statistics, Nonparametric; D013548:Sweden
D003358:Cosmetics