Rationale for use and clinical responsiveness of hexafluoro-1,25-dihydroxyvitamin D3 for the treatment of plaque psoriasis: a pilot study.
BACKGROUND
Vitamin D analogues are useful in topical therapy of psoriasis.


OBJECTIVE
To evaluate the effect of hexafluoro-1,25-dihydroxyvitamin D3 (F6-1,25(OH)2D3) in treatment of psoriasis.


METHODS
Fifteen patients with plaque-type psoriasis were enrolled in a single centre double-blind, right/left comparison, placebo-controlled study, and received 0.1 g of petrolatum containing 5 microg of F6-1,25(OH)2D3 or 0.1 g of petrolatum (placebo) for 3 months. After completion of this double-blind study, a subset of these patients (n = 12) applied F6-1,25(OH)2D3 ointment (50 microg g-1 of petrolatum) to all their lesions (total area, 100-5000 cm2, mean area: 3300 m2) for 2 months as a single application at night.


RESULTS
The mean severity score in the right/left-sided controlled topical F6-1,25(OH)2D3 (50 microg g-1) therapy group showed a decrease of 85%. In contrast, the mean severity score for the placebo-treated areas showed a decrease of 45% (P < 0.001). In the 12 patients who subsequently applied F6-1,25(OH)2D3 (50 microg g-1) ointment to all of their lesions, 91.6% showed moderate to excellent improvement. The mean Psoriasis Area and Severity Index score decreased by 44.9% (from 33.6 +/- 15 to 18.5 +/- 13). No effect on calcium homeostasis was noted. Adverse events included mild irritation in two patients that resolved during therapy.


CONCLUSIONS
Topical F6-1,25(OH)2D3 is a safe and effective once a day treatment for psoriasis.
Vitamin D, Skin, and Bone Research Laboratory, Section of Endocrinology, Nutrition and Diabetes, Department of Medicine, Boston University School of Medicine, 715 Albany St, M-1013, Boston, MA 02118, USA.
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D000328:Adult; D000368:Aged; D002117:Calcitriol / Q000031:analogs & derivatives / Q000627:therapeutic use*; D002118:Calcium / Q000378:metabolism; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010865:Pilot Projects; D011565:Psoriasis / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D005466:Fluorocarbons
D002117:Calcitriol; D002118:Calcium; D003879:Dermatologic Agents; D009824:Ointments; C040488:26,26,26,27,27,27-hexafluoro-1,25-dihydroxyvitamin D3; D005466:Fluorocarbons