Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
Low doses of topically administered vitamin D analogs have been shown to have an
anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly
studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has
been shown to be comparable or slightly more effective than class II corticosteroid
ointments. However, patients had reduced levels of parathyroid hormone; mean serum and urine
calcium were increased during treatment and hypercalciuria was observed. These effects were
reversible with discontinuation of therapy. Thus, while calcipotriol ointment was shown to be
effective, the potential for alterations in calcium homeostasis have limited its use to 100 g
of ointment per week (0.5 mg calcipotriol/week). Work has continued on the creation of new
vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of
hypercalcemia and hypercalciuria with a compound that is more stable and more easily
administered.