Comparison of two formulations of cyclosporin A in the treatment of severe atopic dermatitis. Aa double-blind, single-centre, cross-over pilot study

Dermatology. 1999;198(1):56-60. doi: 10.1159/000018065.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Cross-Over Studies
  • Cyclosporine / administration & dosage
  • Cyclosporine / adverse effects
  • Cyclosporine / therapeutic use*
  • Dermatitis, Atopic / drug therapy*
  • Double-Blind Method
  • Emulsions
  • Female
  • Headache / chemically induced
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Pilot Projects
  • Pruritus / chemically induced
  • Severity of Illness Index
  • Sleep Wake Disorders / chemically induced
  • Time Factors
  • Treatment Outcome

Substances

  • Emulsions
  • Immunosuppressive Agents
  • Cyclosporine