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A Pilot Study

Ingrid M. Zonneveld, MD; Andris Rubins, MD; Stephanie Jablonska, MD; Attila Dobozy, MD; Theo Ruzicka, MD; Peter Kind, MD; Louis Dubertret, MD; Jan D. Bos, MD

Arch Dermatol. 1998;134:1101-1102.

Background  Cyclosporine for the treatment of psoriasis constitutes a new approach. Alternative systemic cyclosporine derivatives have been studied to find an immunosuppressive drug with fewer adverse effects. Tacrolimus is one of these new immunosuppressive drugs. Systemically, it has been proven effective in treating psoriasis. A topical formulation of tacrolimus is attractive because it has fewer adverse effects and is useful for a large group of patients. We report for the first time on the efficacy of nonocclusive topical tacrolimus in the treatment of psoriasis.

Observations  After a washout phase of 2 weeks, patients were randomized to receive 0.005% calcipotriol ointment twice daily, placebo ointment once daily, or 0.3% tacrolimus ointment once daily. One psoriatic plaque was treated with a surface area of 40 to 200 cm². Efficacy was estimated using the local psoriasis severity index. The reduction in the local psoriasis severity index score after 6 weeks was 62.5% in the calcipotriol group, 33.3% in the tacrolimus group, and 42.9% in the placebo group.

Conclusions  There was no statistically significant difference between the efficacy of tacrolimus and placebo ointment (P=.77). Calcipotriol ointment, applied twice daily, had a better effect than tacrolimus ointment and placebo ointment once daily.

From the Departments of Dermatology, Academisch Medisch Centrum, Amsterdam, the Netherlands (Drs Zonneveld and Bos), Latvian Medical Academy, Riga (Dr Rubins), Albert Szent-Györgyi Medical University, Szeged, Hungary (Dr Dobozy), Heinrich Heine University, Düsseldorf, Germany (Dr Ruzicka), Ludwig Maximilians University, Munich, Germany (Dr Kind), Hôpital St Louis, Paris, France (Dr Dubertret), and Klinika Dermatologiczna, Warsaw, Poland (Dr Jablonska).

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