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

Summary 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®, 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.