Peltonen Juha M, Pylkkänen Liisa, Jansén Christer T, Volanen Iina, Lehtinen Terhi, Laihia Jarmo K, Leino Lasse
Clinical Research Services, FIN-20520 Turku, Finland.
Acta Derm Venereol. 2014 Jul;94(4):415-20. doi: 10.2340/00015555-1735.
New treatment modalities are needed in atopic dermatitis. We evaluated the pharmacokinetics, safety, tolerability, and efficacy of topical cis-urocanic acid (cis-UCA) cream in randomised vehicle-controlled double-blinded clinical trials. The subjects received 5% cis-UCA emulsion cream and control vehicle on volar forearms after right-left randomisation. Study 1: 16 healthy subjects received one dose on the skin and, a week later, on DMSO-irritated skin. Study 2: 16 healthy subjects received 2 daily doses for 10 days. Study 3: 13 patients with mild to moderate disease were treated on selected skin lesions twice daily for 28 days. Study treatments were well tolerated. cis-UCA remained close to endogenous levels in plasma and urine. cis-UCA reduced transepidermal water loss (TEWL) both in healthy subjects and in the patients. Eczema area severity index and physician's global assessment improved from baseline with both treatments. cis-UCA cream improved skin barrier function and suppressed inflammation in the human skin.
特应性皮炎需要新的治疗方法。我们在随机赋形剂对照双盲临床试验中评估了外用顺式尿刊酸（cis-UCA）乳膏的药代动力学、安全性、耐受性和疗效。在左右随机分组后，受试者在双侧前臂掌侧分别接受5%顺式-UCA乳剂乳膏和对照赋形剂。研究1：16名健康受试者在皮肤上接受一剂药物，一周后，在经二甲基亚砜刺激的皮肤上再次接受一剂。研究2：16名健康受试者每天接受2剂，共10天。研究3：13例轻至中度疾病患者在选定的皮肤病变处每天接受两次治疗，共28天。研究治疗耐受性良好。顺式-UCA在血浆和尿液中的水平仍接近内源性水平。顺式-UCA在健康受试者和患者中均降低了经表皮水分流失（TEWL）。两种治疗方法均使湿疹面积严重程度指数和医生整体评估较基线有所改善。顺式-UCA乳膏改善了皮肤屏障功能并抑制了人体皮肤炎症。
