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

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.

• Authors: B Zurbriggen, B Wüthrich, A B Cachelin, P B Wili, M K Kägi
• Journal: Dermatology (Basel, Switzerland) (Dermatology) Vol. 198 Issue 1 Pg. 56-60 ( 1999) ISSN: 1018-8665 [Print] Switzerland
• PMID: 10026403 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Emulsions
• Immunosuppressive Agents
• Cyclosporine

Topics

• Adult
• Cross-Over Studies
• Cyclosporine (administration & dosage, adverse effects, therapeutic use)
• Dermatitis, Atopic (drug therapy)
• Double-Blind Method
• Emulsions
• Female
• Headache (chemically induced)
• Humans
• Immunosuppressive Agents (administration & dosage, adverse effects, 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