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Relationship of Dose, Tissue Levels, and Efficacy

Michael K. Burns, MD; Charles N. Ellis, MD; Drore Eisen, MD; Elizabeth Duell, PhD; Christopher E. M. Griffiths, MD, MRCP; Thomas M. Annesley, PhD; Ted A. Hamilton, MS(Biostat); Jay E. Birnbaum, PhD; John J. Voorhees, MD

Arch Dermatol. 1992;128(6):786-790.

Abstract
• Background and Design.—
To avoid systemic side effects, topical and intralesional administration of cyclosporine has been used; however, only intralesional administration has been successful. To understand more about the dosing requirements and resultant tissue levels of intralesional cyclosporine, we injected psoriasis plaques in a double-blind fashion with three different concentrations of cyclosporine (17 mg/mL in seven patients, 10 mg/mL in 13 patients, and 2.5 mg/mL in 11 patients) or matching vehicle three times weekly for 4 weeks.

Results.—
Statistically significant improvement was observed in plaques treated with 17 mg/mL (P =.003) compared with vehicle-treated plaques; the improvements in plaques treated with 10 mg/mL (P=.078) and 2.5 mg/mL (P=.054) achieved marginal statistical significance compared with vehicle treatment. Four weeks after discontinuation of ther

Author Affiliations
From the Dermatopharmacology Unit, Department of Dermatology (Drs Burns, Ellis, Eisen, Duell, Griffiths, and Voorhees and Mr Hamilton) and Department of Pathology (Dr Annesley), University of Michigan Medical Center, Ann Arbor; and Sandoz Research Institute, East Hanover, NJ (Dr Birnbaum).

Footnotes
Accepted for publication October 10, 1991.

Read in part before the Fifth International Psoriasis Symposium, San Francisco, Calif, July 13, 1991.

Reprint requests to Department of Dermatology, University of Michigan Medical Center, 1910 Taubman Center, Ann Arbor, MI 48109-0314 (Dr Voorhees).

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ABSTRACT