The efficacy of topical active vitamin D<sub>3</sub> and steroid combination therapy (topical drug combination)in Japanese patients with psoriasis vulgaris: phaseⅢ study subset anylysis

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  • 日本人尋常性乾癬患者における活性型ビタミンD<sub>3</sub>/ ステロイド配合外用薬（ドボベット®軟膏）の有効性 ─国内第Ⅲ相試験のサブ解析─
  • 日本人尋常性乾癬患者における活性型ビタミンD₃/ステロイド配合外用薬(ドボベット軟膏)の有効性 : 国内第Ⅲ相試験のサブ解析
  • ニホンジン ジンジョウセイカンセンカンジャ ニ オケル カッセイガタ ビタミン D ₃/ステロイド ハイゴウ ガイヨウヤク(ドボベット ナンコウ)ノ ユウコウセイ : コクナイ ダイ Ⅲ ソウ シケン ノ サブ カイセキ

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Abstract Purpose : To investigate the efficacy of topical active vitamin D3 and steroid combination therapy(topical drug combination)in Japanese patients with psoriasis vulgaris. Methods : Efficacy of the topical combination treatment was explored by performing a subanalysis of a double-blind, 3-group, parallel comparative study in which patients with psoriasis vulgaris were randomized to the topical combination drug(applied once daily)group, calcipotriol(applied twice daily)group, or betamethasone dipropionate(applied once daily)group, and received treatment for 4 weeks. The time to onset of improving effect of the topically applied drug combination was examined using the physician's assessments and patients' self-assessments, and the possible factors affecting the therapeutic effect were investigated. Results : Both physician's assessment(percent change in m-PASI, composite severity score for target disease, global assessment of disease severity)and patient's self-assessment(global assessment of disease severity)demonstrated the combination treatment to have a superior effect 1 week after initiation compared to that of topical calcipotriol or betamethasone dipropionate. Furthermore, a similar effect was observed after 4 weeks. The effect of the topical combination therapy slightly decreased in obese patients(BMI ” 30) ; however, this decrease was lower than that observed for topical betamethasone dipropionate. The other investigated factors did not have any effect on the efficacy of the topical combination therapy. Conclusion : Once-daily application of the topical drug combination promptly improved the skin symptoms in patients with psoriasis vulgaris 1 week after initiation of treatment regardless of the patient factors.

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