The effect of elidel 1% cream on skin condition and sleep parameters in children with mild to moderate atopic dermatitis (AD)

Abstract Rationale Children with atopic dermatitis (AD) have disturbed sleep patterns due to itching. Actigraphy is an objective measurement of nocturnal wakening and sleep. We evaluated the efficacy of pimecrolimus 1% cream in improving skin condition and nocturnal waking by reduction of itching and scratching. Methods Seventeen total patients ages 7-15 with mild to moderate AD were randomized to either placebo or pimecrolimus 1% cream for two weeks after a one week wash out with moisturizer. Eczema Area and Severity Index (EASI) scores, mean wake episodes, and mean wake minutes were generated by continuous actigraphy. No anti-histamines, sleep medications, or topical corticosteroids were used during the study. EASI scores, questionnaires about sleep, itching, and quality of life were obtained each week. Results Baseline wake minutes, wake episodes, and EASI scores (expressed as mean ± SD) were similar between pimecrolimus (43.7 ± 21minutes; 14.9 ± 8 episodes; 12.2 ± 8) and placebo (44.6 ± 25 minutes; 14.9 ± 4.3 episodes; 9.8 ± 4.8). Week 3 EASI scores improved in pimecrolimus (5.6 ± 4.3) versus placebo (10.4 ± 7) (p=0.02). The pimecrolimus group also demonstrated a trend in decreased wake minutes versus placebo (36.6 ± 17 minutes; 51 ± 37.9 minutes; p=0.1) and wake episodes (11.3 ± 5.6 episodes; 13.3 ± 7 episodes; p=0.2) respectively. Wake minutes and episodes correlated with EASI scores (r=0.39, p=0.1; r=0.63, p=0.01 respectively). Conclusions Pimecrolimus 1% cream significantly reduces the extent and severity of AD within two weeks. Furthermore, a favorable trend was observed for reduction in overall sleep disturbance. These data suggest that further research is warranted to determine whether longer treatment with pimecrolimus will modify sleep disturbance in AD.