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Results of a Randomized, Double-blind, Vehicle-Controlled, Right/Left Comparative Study

Knud Kragballe, MD; Peter M. Steijlen, MD; Hans Henning Ibsen, MD; Peter C. M. van de Kerkhof, MD; Jorgen Esmann, MD; Lars Halkier Sorensen, MD; Mads Buhl Axelsen,n, MD

Arch Dermatol. 1995;131(5):556-560.

Abstract
Background and Design
Disorders of keratinization are a heterogeneous group of diseases that have in common a defect in cornification. The bioactive form of vitamin D₃ has been shown to modulate epidermal proliferation and differentiation. The purpose of the present study was to determine the effect of the synthetic vitamin D₃ calcipotriol in a randomized, double-blind, placebo-controlled, right/left comparative study. The 67 patients included in the study were at least 12 years of age and had the following diseases: ichthyosis vulgaris (n=9), X-linked ichthyosis (n=8), congenital ichthyosis (n=10), hereditary palmoplantar keratoderma (n=20), keratosis pilaris (n=9), and Darier's disease (n=11). Calcipotriol ointment (50 µg/g) and placebo (vehicle of calcipotriol ointment) were applied to all patients twice daily for up to 12 weeks. The patients were allowed to use up to 120 g of calcipotriol ointment per week.

Results
At the end of the treatment regimen, calcipotriol ointment had an effect on the improvement of the ichthyoses, although to a variable degree. No therapeutic effect was detected in palmoplantar keratoderma or keratosis pilaris. Eight of 12 patients with Darier's disease had to be withdrawn because of skin irritation or a worsening of the disease. Skin irritation occurred in 18 cases (26%) only on the calcipotriol-treated side, and in one case (1%) only on the placebo-treated side. Nine cases (13%) had irritation on both sides. The amount of calcipotriol ointment used per week was lowest in palmoplantar keratoderma (mean, 11.8 g/wk; range, 2.1 to 25.6 g/wk) and highest in congenital ichthyosis (mean, 59.3 g/wk; range, 11.4 to 94.7 g/wk). There was no clinically significant change of serum calcium levels during the treatment period.

Conclusion
Short-term treatment with calcipotriol ointment (50 µg/g) used in amounts up to about 100 g/wk is moderately efficacious, well-tolerated, and safe in adult patients with various ichthyoses.

(Arch Dermatol. 1995;131:556-560)

Author Affiliations
From the Department of Dermatology, University Hospital Aarhus (Denmark) (Drs Kragballe and Esmann); Department of Dermatology, University Hospital Nijmegen (the Netherlands) (Drs Steijlen and van de Kerkhof); Department of Dermatology, University Hospital Odense (Denmark) (Drs Ibsen and Sorensen); and Leo Pharmaceutical Products, Ballerup, Denmark (Dr Axelsen).

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