Efficacy, tolerability, and safety of calcipotriol ointment in disorders of keratinization. Results of a randomized, double-blind, vehicle-controlled, right/left comparative study.

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 micrograms/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 Eight of 12 patients with Darier's disease had to be withdrawn because of skin irritation or a worsening of the disease.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 micrograms/g) used in amounts up to about 100 g/wk is moderately efficacious, well-tolerated, and safe in adult patients with various ichthyoses.