HEXAFLUORO 1 ALPHA 25 DIHYDROXYVITAMIN D3 & DOVONEX FOR TREATING PSORIASIS

六氟 1 ALPHA 25 二羟基维生素 D3

• 批准号: 6264934
• 负责人: MICHAEL F HOLICK
• 金额: $ 3.05万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264934
• 关键词: 1,25 dihydroxycholecalciferol; adult human (21+); clinical research; clinical trials; dosage; drug vehicle; human subject; human therapy evaluation; psoriasis; skin disorder chemotherapy; topical drug application; vitamin therapy

The goal of this pilot is to determine the therapeutic efficacy and safety of two formulations of vitamin D analog 25,25,25,27,27,27-Hexafluoro-1 Alpha, 25-dihydroxyvitamin D3 for treatment of plaque psoriasis in adults. This will be accomplished by evaluating the topical application of two petrolatum-based formulations containing F6-1, 25(OH)2D3. The safety and efficacy of these two formulations will be compared with the safety and efficacy of placebo vehicle or Dovonex, a commercially available prescription product which contains a vitamin D analog. A total of up to 45 adults patients with plaque type psoriasis who have lesions over at least 5% of their bodies will be studied. Study subjects will be male and female between the ages of 18-80. The study will be for a total of two months of treatment. One of the test materials will be applied by the patient at the dose of approximately 0.05G to a 25 CM2 lesion. A comparable 25 CM2 psoriasis lesion will receive 0.05 of second test material. The third lesion will receive either 0.05G of petrolatum or Dovonex.

本试验的目的是确定两种维生素D类似物25，25，25，27，27，27-六氟-1 α，25-二羟基维生素D3制剂治疗成人斑块状银屑病的疗效和安全性。这将通过评价两种含F6-1，25（OH）2D 3的凡士林制剂的局部应用来实现。 将这两种制剂的安全性和有效性与安慰剂载体或Dovonex（一种含有维生素D类似物的市售处方产品）的安全性和有效性进行比较。 总共将研究多达45名斑块型银屑病成人患者，这些患者的病变至少超过其身体的5%。 研究受试者为18-80岁的男性和女性。 该研究将进行总共两个月的治疗。 将由患者以约0.05G的剂量将其中一种试验材料应用于25 CM 2病变。 可比较的25 cm 2银屑病病灶将接受0.05的第二种试验材料。 第三处病变将接受0.05G矿脂或Dovonex。