J Traulsen1, B J Hughes-Formella. 1. Dermatological Medical Department, LEO Pharma, Ballerup, Denmark. jette.trulsen@leo-pharma.com
Abstract
BACKGROUND: 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. OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: The atrophogenic potential of Daivobet and Diprosone was similar following twice daily application over a 4-week treatment period. Skin irritation was not observed. Copyright 2003 S. Karger AG, Basel
RCT Entities:
BACKGROUND: 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. OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: The atrophogenic potential of Daivobet and Diprosone was similar following twice daily application over a 4-week treatment period. Skin irritation was not observed. Copyright 2003 S. Karger AG, Basel
Authors: J-P Ortonne; M Esposito; S Chimenti; M Kapińska-Mrowiecka; A Grodzińska; L Naldi; V Frangione Journal: J Eur Acad Dermatol Venereol Date: 2013-10-29 Impact factor: 6.166