BACKGROUND:Cyclosporin A (CsA) has been shown to be highly effective in the therapy of atopic dermatitis (AD). However, little information exists on the treatment of AD patients with Sandimmun Neoral(R) (Neoral), a microemulsion of CsA with improved pharmacokinetic properties in comparison to Sandimmun(R). OBJECTIVE: We have compared the efficacy and tolerability of Sandimmun and Neoral. METHODS: In a randomised, monocentric, double-blind, cross-over pilot study (n = 14), each formulation was administered for 8 weeks, followed by switching to the other treatment group for another 8 weeks. RESULTS: After 2 weeks of therapy, the improvement under Neoral therapy was significantly higher than with Sandimmun (disease activity p = 0.047; extent of disease p = 0.016). In contrast, after 8 weeks of therapy, both formulations yielded similar improvement in the patients' condition. CONCLUSION: While both formulations are effective and well tolerated in the treatment of severe AD, Neoral may have a faster onset of action and higher initial efficacy, which makes it an adequate replacement for Sandimmun.
RCT Entities:
BACKGROUND: Cyclosporin A (CsA) has been shown to be highly effective in the therapy of atopic dermatitis (AD). However, little information exists on the treatment of ADpatients with Sandimmun Neoral(R) (Neoral), a microemulsion of CsA with improved pharmacokinetic properties in comparison to Sandimmun(R). OBJECTIVE: We have compared the efficacy and tolerability of Sandimmun and Neoral. METHODS: In a randomised, monocentric, double-blind, cross-over pilot study (n = 14), each formulation was administered for 8 weeks, followed by switching to the other treatment group for another 8 weeks. RESULTS: After 2 weeks of therapy, the improvement under Neoral therapy was significantly higher than with Sandimmun (disease activity p = 0.047; extent of disease p = 0.016). In contrast, after 8 weeks of therapy, both formulations yielded similar improvement in the patients' condition. CONCLUSION: While both formulations are effective and well tolerated in the treatment of severe AD, Neoral may have a faster onset of action and higher initial efficacy, which makes it an adequate replacement for Sandimmun.
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
Authors: Robert Sidbury; Dawn M Davis; David E Cohen; Kelly M Cordoro; Timothy G Berger; James N Bergman; Sarah L Chamlin; Kevin D Cooper; Steven R Feldman; Jon M Hanifin; Alfons Krol; David J Margolis; Amy S Paller; Kathryn Schwarzenberger; Robert A Silverman; Eric L Simpson; Wynnis L Tom; Hywel C Williams; Craig A Elmets; Julie Block; Christopher G Harrod; Wendy Smith Begolka; Lawrence F Eichenfield Journal: J Am Acad Dermatol Date: 2014-05-09 Impact factor: 11.527