Tolérance clinique des antiseptiques cutanés chez 3 403 malades en pratique de ville

Abstract

We prospectively studied the prevalence and the clinical forms of adverse cutaneous reactions associated with the main antiseptics used in France, the incidence of which is not well known. Patients were included by 773 French dermatologists from May to June 2003. The 8 first consecutive adult patients for whom ambulatory treatment with a cutaneous antiseptic was prescribed were included. Patients were evaluated at inclusion and after treatment, either in person or by telephone. All reported adverse cutaneous reactions were validated by two independent experts. 3,403 patients (61% women, 39% men; mean age: 47) were included. Antiseptics were indicated for ambulatory surgery (45%), technical procedures (33%), and in combination with other treatments for various dermatoses, wounds and burns (12%). The 6 most widely used treatments (96% of prescriptions) were hexamidine (37%), chlorhexidine-benzalkonium (28%), chlorhexidine-alcohol (16.5%), aqueous chlorhexidine (7%), polyvidone iodine (6%) and hexamidine-chlorhexidine (1.8%). The antiseptic was prescribed for application by dabbing (57%) or spraying (40%), twice daily for a mean 10 days (3-30 days). A transient burning sensation was noticed by 4 to 7% of the patients, without any significant difference between antiseptics. Twelve adverse events were reported: contact dermatitis in 9 patients, persistent burning sensation in 2 and yellow discoloration of the skin in one. This latter case, caused by the colour of the antiseptic, cannot be considered as an adverse event. Furthermore one patient with contact dermatitis should have not been included because he had a history of cutaneous reaction related to the use of the same antiseptic. Therefore only 10 cutaneous reactions were eventually taken into account (overall prevalence=2.9 per thousand, ranging from 0% to 0.5% according to the antiseptic). There was no significant difference in terms either of the antiseptic used or the site of the treated lesion. A history of contact dermatitis was associated with a significant risk of adverse reaction (OR=7.2; CI 95: 2.0-26.4; p=0.007). The median time from onset of treatment to appearance of contact dermatitis was 4 days (0-90 days). The condition resolved following discontinuation of treatment; spontaneously in 5 patients and with dermocorticoid therapy in 5 others. The results of this study give a precise idea of how the antiseptics are used by French dermatologists in clinical practice in outpatients and how often their use is complicated by the occurrence of adverse cutaneous reactions. The low rate of such reactions (2.9 per thousand) in our study is thus in contrast with the impression given by the large number of publications related to this complication. It also tempers the high rates of sensitisation to various antiseptics found in selected at-risk patients. The most common adverse event observed was contact dermatitis and a history of this condition conferred a significant risk of cutaneous reaction. Although cutaneous antiseptics are well tolerated with a low prevalence of adverse reactions, generally mild, they should nevertheless be prescribed with caution in patients with a history of contact dermatitis.