EFFICACY AND SAFETY OF THE 20-EPI-VITAMIN-D-3 ANALOG KH-1060 IN THE TOPICAL THERAPY OF PSORIASIS - RESULTS OF A DOSE-RANGING STUDY

KH 1060 is a 20-epi-vitamin D-3 analogue, structurally related to 1,25 -dihydroxyvitamin D-3 (1,25(OH)(2)D-3). In vitro, KH 1060 is much more potent than 1,25(OH)(2)D-3 in regulating cell growth and T lymphocyte mediated immune responses, despite a similar calcemic activity in viv o. Therefore, KH 1060 is of potential interest in the treatment of pso riasis and other diseases characterized by accelerated cell growth and T lymphocyte activation. In a multicenter, prospective, randomized, d ouble-blind, vehicle-controlled right/left comparative study, patients with plaque-type psoriasis vulgaris were randomly assigned to one of the following treatment groups: (I) KH 1060 ointment 0.2 mu g/g versus placebo ointment, (II) KH 1060 ointment 0.2 mu g/g versus KH 1060 oin tment 0.04 mu g/g, and (III) KH 1060 ointment 0.2 mu g/g versus KH 106 0 ointment 1 mu g/g. All treatments were given twice daily for 6 weeks . Sixty-four of the 70 randomized patients completed the study. At the end of treatment, no difference was demonstrated between KH 1060 0.04 mu g/g and vehicle, whereas significantly increasing improvement was found for the doses KH 1060 0.2 mu g/g and KH 1060 1 mu g/g. According to the investigator's overall assessments at the end of treatment, KH 1060 1.0 mu g/g and KH 1060 0.2 mu g/g produced a marked or moderate improvement in most patients. Mild lesional irritation was observed af ter treatment with KH 1060 as well as with placebo. One patient was wi thdrawn because of an eczematous reaction, where KH 1060 1.0 mu g/g wa s applied. There was no change of serum calcium levels during the trea tment. In conclusion, at the dosages tested topical KH 1060 induces a moderate improvement of psoriasis without causing any significant side -effects.