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Addition of fexofenadine to a topical corticosteroid reduces the pruritus associated with atopic dermatitis in a 1-week randomized, multicentre, double-blind, placebo-controlled, parallel-group study


  • Disclosure statement: Makoto Kawashima, Toshiro Tango, Hidemi Nakagawa and Shotaro Harada have received payments for conducting and publicizing this study from Aventis Pharma Ltd. (Japan). Masahito Inagi and Tomoo Noguchi are employees of Aventis Pharma Ltd. (Japan). The authors have no commercial associations that might pose a conflict of interest and no associations with companies that make a competing product.

Makoto Kawashima (Director) E-mail:


SummaryBackground Fexofenadine, a nonsedating, H1-receptor selective antihistamine, exhibits consistent efficacy and safety in the treatment of allergic rhinitis and urticaria. The pruritus associated with atopic dermatitis is considered to be induced, in part, by histamine. Therefore, we thought that fexofenadine may be useful in the relief of pruritus associated with atopic dermatitis.

Objective To compare the efficacy of twice-daily fexofenadine hydrochloride (HCl) 60 mg vs. placebo in reducing the pruritus associated with atopic dermatitis.

Methods In this randomized, multicentre, double-blind, placebo-controlled study, patients (aged ≥ 16 years) with atopic dermatitis underwent a 1-week placebo lead-in period, followed by randomization to fexofenadine HCl 60 mg twice daily or placebo for 1 week. All patients also received topical treatment with 0·1% hydrocortisone butyrate twice daily throughout the study. The primary efficacy endpoint was mean change in pruritus score from baseline. Patients reflectively recorded pruritus scores twice daily (day and night) using a five-point scale (0 = none; 4 = very severe).

Results Fexofenadine (n = 201) significantly decreased the severity of pruritus compared with placebo (n = 199) (mean change in score −0·75 (unadjusted 95% confidence interval [−0·88, −0·62]) vs. −0·5 [−0·62, −0·38], respectively; P = 0·0005). This improvement was seen after just 1 day of treatment (P = 0·039) and was maintained throughout the treatment period (P = 0·019). Compared with placebo, fexofenadine significantly improved both diurnal (P = 0·0001) and nocturnal pruritus (P = 0·013). In addition, significantly more patients in the fexofenadine group experienced a reduction in the ratio of pruritus area to body surface area compared with those in the placebo group (P = 0·007). The incidence of adverse events was low and similar across all treatment groups.

Conclusions Fexofenadine HCl 60 mg twice daily demonstrated a rapid, significant improvement in the pruritus associated with atopic dermatitis, with a safety profile equivalent to that of placebo.