High-concentration (20 μg g−1) tacalcitol ointment in the treatment of facial psoriasis: an 8-week open-label clinical trial

Abstract

Background Facial psoriasis gives rise to considerable concern because of associated cosmetic problems and psychosocial distress. It requires a treatment approach other than topical corticosteroids, which bear a risk of cutaneous adverse reactions. Recently, topical tacalcitol has been shown to be effective in psoriasis. Objectives The aim of this open-label single-centre study is to investigate the efficacy and safety of high-concentration (20 μg g(-1)) tacalcitol ointment (Bonalfa-high (R), Teijin Pharma, Tokyo, Japan) in patients with facial psoriasis and to evaluate clinical response according to the distribution of facial psoriatic lesions. Patients and methods Thirty-seven patients were enrolled to this clinical trial. Tacalcitol 20 μg g(-1) ointment was applied once daily to psoriatic lesions of the face over an 8-week period. Patients were also categorized into three subtypes according to facial lesion distribution. Efficacy was evaluated by the facial Psoriasis Area and Severity Index (facial PASI) and the Physician`s Global Assessment (PGA) score at weeks 2, 4 and 8. The Subjective Global Assessment (SGA) was also determined at the end of the study. Results Thirty-three patients completed the clinical trial. Mean facial PASI of 33 patients at baseline was 9.58 and after 8 weeks of treatment the mean facial PASI decreased significantly to 3.88. By using PGA, patients showed the following responses to treatment: clearance (n = 1); excellent (6); good (16); fair (4); slight (5); no change (1). The response rate among the three facial psoriasis types showed no difference. Using the SGA, 27 (82%) of the patients presented excellent (15%) or good (67%) effect with tacalcitol 20 μg g(-1) ointment. No serious adverse reactions were observed. Conclusions This is the first clinical study reporting a relevant therapeutic effect and favourable safety profile of tacalcitol 20 μg g(-1) ointment in facial psoriasis. These results suggest that tacalcitol 20 μg g(-1) ointment can be used as the first-line treatment in patients with facial psoriasis.