Journal of drugs in dermatology : JDD · 2008
Topical tacrolimus 0.1% improves symptoms of hand dermatitis in patients treated with a prednisone taper.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Krejci-Manwaring Jennifer, McCarty Martha Ann, Camacho Fabian, Manuel Janeen, Hartle Jennifer, Fleischer Alan, Feldman Steven R
Аннотация
BACKGROUND: Hand dermatitis is a chronic inflammatory skin disorder for which systemic immunosuppressive therapy is often needed. Topical treatments could complement the use of systemic corticosteroids.
OBJECTIVE: To evaluate symptoms of hand dermatitis in subjects treated with a prednisone taper combined with topical tacrolimus 0.1% ointment versus vehicle.
METHODS: Thirty-two subjects with moderate to severe hand dermatitis were enrolled in a randomized double-blind controlled trial. Subjects received a 3-week taper of prednisone and was randomized 2:1 to apply topical tacrolimus or its vehicle twice daily for 12 weeks. Disease severity was evaluated at baseline and at 5 follow-up visits (weeks 1-14). Any occurrence of relapse was recorded by patients.
RESULTS: Twenty-two of the 32 subjects (69%) had relapse of their disease. The mean time to recurrence for tacrolimus versus vehicle was 48 versus 39 days, respectively (P = .78). A greater improvement of induration (P = .003) and scaling (P = .003) for patients with tacrolimus compared to vehicle was detected, as well as subjective improvement (%) from week 1 to week 12 (P = .04) compared to vehicle. Improvement in erythema (P < .0001), fissuring (P = .0003), pruritus (P = .06), and investigator's global assessment (P < .0001) with tacrolimus was not found to exceed improvement with vehicle.
LIMITATIONS: Small sample size provides limited power to detect differences in response.
CONCLUSIONS: Topical tacrolimus improves induration and scaling, and there is a trend suggesting it prolongs the time to recurrence.
OBJECTIVE: To evaluate symptoms of hand dermatitis in subjects treated with a prednisone taper combined with topical tacrolimus 0.1% ointment versus vehicle.
METHODS: Thirty-two subjects with moderate to severe hand dermatitis were enrolled in a randomized double-blind controlled trial. Subjects received a 3-week taper of prednisone and was randomized 2:1 to apply topical tacrolimus or its vehicle twice daily for 12 weeks. Disease severity was evaluated at baseline and at 5 follow-up visits (weeks 1-14). Any occurrence of relapse was recorded by patients.
RESULTS: Twenty-two of the 32 subjects (69%) had relapse of their disease. The mean time to recurrence for tacrolimus versus vehicle was 48 versus 39 days, respectively (P = .78). A greater improvement of induration (P = .003) and scaling (P = .003) for patients with tacrolimus compared to vehicle was detected, as well as subjective improvement (%) from week 1 to week 12 (P = .04) compared to vehicle. Improvement in erythema (P < .0001), fissuring (P = .0003), pruritus (P = .06), and investigator's global assessment (P < .0001) with tacrolimus was not found to exceed improvement with vehicle.
LIMITATIONS: Small sample size provides limited power to detect differences in response.
CONCLUSIONS: Topical tacrolimus improves induration and scaling, and there is a trend suggesting it prolongs the time to recurrence.