BACKGROUND: Previous studies suggested that early intervention with pimecrolimus cream 1% at the first signs and/or symptoms of a relapse of atopic dermatitis (AD) following remission may prevent the occurrence of more severe flares and therefore reduce corticosteroid exposure in the long term. However, this possibility was not rigorously evaluated. OBJECTIVES: To evaluate the effectiveness of pimecrolimus cream 1% for the prevention of flare progression in adults with AD. METHODS: A 26-week randomized controlled study was conducted in 543 patients aged>or=18 years, with a history of mild or moderate AD, who were clear/almost clear of disease before randomization to pimecrolimus cream 1% (n=277) or matching vehicle cream (n=266). Twice-daily treatment with study medication was started at the onset of the first signs and/or symptoms of a relapse. If disease worsened, despite the application of study medication for at least 3 days, treatment with a moderately potent topical corticosteroid (TCS) was allowed in both groups. The primary efficacy endpoint was the number of days without TCS use for disease worsening. RESULTS: The mean number of TCS-free days was significantly higher (P<0.001) in the pimecrolimus cream 1% group (152 days) than in the vehicle cream group (138.7 days). In comparison with vehicle cream, pimecrolimus cream 1% reduced the mean number of flares requiring TCS use from 1.39 to 0.97 (P=0.0014). Patients on pimecrolimus cream 1% made 30% fewer unscheduled visits (156) than patients on vehicle cream (223). CONCLUSIONS: In adults with a history of mild or moderate AD but free of active skin lesions, intervention with pimecrolimus cream 1% at the first signs and/or symptoms of a subsequent recurrence reduces the number of flares requiring TCS use and decreases the number of disease-related office visits.
RCT Entities:
BACKGROUND: Previous studies suggested that early intervention with pimecrolimuscream 1% at the first signs and/or symptoms of a relapse of atopic dermatitis (AD) following remission may prevent the occurrence of more severe flares and therefore reduce corticosteroid exposure in the long term. However, this possibility was not rigorously evaluated. OBJECTIVES: To evaluate the effectiveness of pimecrolimuscream 1% for the prevention of flare progression in adults with AD. METHODS: A 26-week randomized controlled study was conducted in 543 patients aged>or=18 years, with a history of mild or moderate AD, who were clear/almost clear of disease before randomization to pimecrolimuscream 1% (n=277) or matching vehicle cream (n=266). Twice-daily treatment with study medication was started at the onset of the first signs and/or symptoms of a relapse. If disease worsened, despite the application of study medication for at least 3 days, treatment with a moderately potent topical corticosteroid (TCS) was allowed in both groups. The primary efficacy endpoint was the number of days without TCS use for disease worsening. RESULTS: The mean number of TCS-free days was significantly higher (P<0.001) in the pimecrolimuscream 1% group (152 days) than in the vehicle cream group (138.7 days). In comparison with vehicle cream, pimecrolimuscream 1% reduced the mean number of flares requiring TCS use from 1.39 to 0.97 (P=0.0014). Patients on pimecrolimuscream 1% made 30% fewer unscheduled visits (156) than patients on vehicle cream (223). CONCLUSIONS: In adults with a history of mild or moderate AD but free of active skin lesions, intervention with pimecrolimuscream 1% at the first signs and/or symptoms of a subsequent recurrence reduces the number of flares requiring TCS use and decreases the number of disease-related office visits.
Authors: Mark G Lebwohl; James Q Del Rosso; William Abramovits; Brian Berman; David E Cohen; Emma Guttman; Anthony J Mancini; Lawrence A Schachner Journal: J Clin Aesthet Dermatol Date: 2013-07
Authors: Jung Eun Kim; Hyun Jeong Kim; Bark-Lynn Lew; Kyung Ho Lee; Seung Phil Hong; Yong Hyun Jang; Kui Young Park; Seong Jun Seo; Jung Min Bae; Eung Ho Choi; Ki Beom Suhr; Seung Chul Lee; Hyun Chang Ko; Young Lip Park; Sang Wook Son; Young Jun Seo; Yang Won Lee; Sang Hyun Cho; Chun Wook Park; Joo Young Roh Journal: Ann Dermatol Date: 2015-10-02 Impact factor: 1.444