BACKGROUND: There is a need for alternative treatments for atopic dermatitis (AD) of the face and neck as long-term use of topical corticosteroids (TCS) is associated with skin atrophy and telangiectasia and some patients develop allergy, intolerance or other side-effects. OBJECTIVES: This study was designed to assess the efficacy and safety of pimecrolimus cream 1% in patients with AD of the face and neck who are either dependent on, or intolerant of, TCS. METHODS: A 12-week study comprising a 6-week, double-blind, randomized, vehicle-controlled phase was conducted, followed by a 6-week, open-label phase. Two hundred patients aged 12 years or over with mild to moderate head and neck AD, intolerant of, or dependent on, TCS were randomized to either pimecrolimus cream or vehicle cream. The primary efficacy criterion was the facial investigator's global assessment score at 6 weeks. Secondary efficacy criteria were head and neck Eczema Area and Severity Index (EASI), pruritus score and eyelid dermatitis. Facial skin atrophy and telangiectasia were assessed with dermatoscopy. RESULTS: A significantly higher percentage of patients treated with pimecrolimus was cleared or almost cleared of facial AD compared with vehicle (47% vs. 16%, respectively). A statistically significant difference was also seen on head and neck EASI and pruritus score. Significantly more pimecrolimus-treated patients than vehicle-treated patients achieved clearance of eyelid dermatitis (45% vs. 19%, respectively). Among the 77 patients with skin atrophy at baseline, treatment withpimecrolimus was associated with a reversal in skin thinning. Of the 112 patients with telangiectasia at baseline, no statistically significant difference was seen between treatment groups. Adverse events occurred with similar frequency in both groups. CONCLUSION:Pimecrolimus cream 1% is effective in patients with head and neck dermatitis intolerant of, or dependent on, TCS. Reversion of skin atrophy may occur during TCS-free intervals.
RCT Entities:
BACKGROUND: There is a need for alternative treatments for atopic dermatitis (AD) of the face and neck as long-term use of topical corticosteroids (TCS) is associated with skin atrophy and telangiectasia and some patients develop allergy, intolerance or other side-effects. OBJECTIVES: This study was designed to assess the efficacy and safety of pimecrolimuscream 1% in patients with AD of the face and neck who are either dependent on, or intolerant of, TCS. METHODS: A 12-week study comprising a 6-week, double-blind, randomized, vehicle-controlled phase was conducted, followed by a 6-week, open-label phase. Two hundred patients aged 12 years or over with mild to moderate head and neck AD, intolerant of, or dependent on, TCS were randomized to either pimecrolimus cream or vehicle cream. The primary efficacy criterion was the facial investigator's global assessment score at 6 weeks. Secondary efficacy criteria were head and neck Eczema Area and Severity Index (EASI), pruritus score and eyelid dermatitis. Facial skin atrophy and telangiectasia were assessed with dermatoscopy. RESULTS: A significantly higher percentage of patients treated with pimecrolimus was cleared or almost cleared of facial AD compared with vehicle (47% vs. 16%, respectively). A statistically significant difference was also seen on head and neck EASI and pruritus score. Significantly more pimecrolimus-treated patients than vehicle-treated patients achieved clearance of eyelid dermatitis (45% vs. 19%, respectively). Among the 77 patients with skin atrophy at baseline, treatment with pimecrolimus was associated with a reversal in skin thinning. Of the 112 patients with telangiectasia at baseline, no statistically significant difference was seen between treatment groups. Adverse events occurred with similar frequency in both groups. CONCLUSION:Pimecrolimuscream 1% is effective in patients with head and neck dermatitis intolerant of, or dependent on, TCS. Reversion of skin atrophy may occur during TCS-free intervals.
Authors: Lawrence F Eichenfield; Wynnis L Tom; Timothy G Berger; Alfons Krol; Amy S Paller; Kathryn Schwarzenberger; James N Bergman; Sarah L Chamlin; David E Cohen; Kevin D Cooper; Kelly M Cordoro; Dawn M Davis; Steven R Feldman; Jon M Hanifin; David J Margolis; Robert A Silverman; Eric L Simpson; Hywel C Williams; Craig A Elmets; Julie Block; Christopher G Harrod; Wendy Smith Begolka; Robert Sidbury Journal: J Am Acad Dermatol Date: 2014-05-09 Impact factor: 11.527
Authors: David Luk; Kam Lun Ellis Hon; Maria Victoria C Dizon; Kin-Fon Leong; Yong-Kwang Tay; Mark Jean-Aan Koh; Nisha Suyien Chandran; Siriwan Wananukul; Susheera Chatproedprai; Thomas Luger Journal: Dermatol Ther (Heidelb) Date: 2020-12-12
Authors: Hyun Chang Ko; Woo Il Kim; Sang Hyun Cho; Young Lip Park; Eung Ho Choi; Sang Wook Son; Bark Lynn Lew; Yang Won Lee; Young Jun Seo; Gyong Moon Kim; Joon Hong Min; Chan Ho Na; Chong Hyun Won; Hyoseung Shin; Kwang Hoon Lee; Joo Young Roh; Young Min Park; Yong Hyun Jang; Seok Kweon Yun; You Chan Kim; Gyeong Hun Park; Chun Wook Park Journal: Ann Dermatol Date: 2018-02-21 Impact factor: 1.444