Traulsen J, Hughes-Formella B J
Dermatological Medical Department, LEO Pharma, Ballerup, Denmark.
Dermatology. 2003;207(2):166-72. doi: 10.1159/000071788.
Recently, a combination product (Daivobet) ointment: calcipotriol 50 micro g/g, betamethasone dipropionate 0.5 mg/g) has been developed for the treatment of psoriasis.
This study aimed to demonstrate that the atrophogenic potential of Daivobet is less or equal to the skin thinning produced by Diprosone (betamethasone dipropionate 0.05 mg/g).
The forearms of 45 subjects were treated with Daivobet and Diprosone or Daivobet and its vehicle twice daily over a 4-week period. Sonographic measurements for full skin thickness, clinical assessments and biopsies were carried out.
A confidence interval approach was used to establish that skin thinning following treatment with Daivobet was equal to or less than thinning with Diprosone. Histological results did not suggest differences between Daivobet and Diprosone. Clinical signs of atrophy or irritation were not observed.
The atrophogenic potential of Daivobet and Diprosone was similar following twice daily application over a 4-week treatment period. Skin irritation was not observed.
最近，一种复方制剂（得肤宝）软膏（钙泊三醇50μg/g，二丙酸倍他米松0.5mg/g）已被开发用于治疗银屑病。
本研究旨在证明得肤宝的致萎缩潜力小于或等于适确得（二丙酸倍他米松0.05mg/g）所导致的皮肤变薄。
45名受试者的前臂在4周内每天两次分别使用得肤宝和适确得，或得肤宝及其赋形剂。进行了全皮肤厚度的超声测量、临床评估和活检。
采用置信区间法确定，得肤宝治疗后的皮肤变薄程度等于或小于适确得。组织学结果未提示得肤宝与适确得之间存在差异。未观察到萎缩或刺激的临床体征。
在4周治疗期内每天两次应用后，得肤宝和适确得的致萎缩潜力相似。未观察到皮肤刺激现象。
