Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

Basilea Pharmaceutica2 个研究点分布在 1 个国家目标入组 300 人开始时间: 2005年3月最近更新: 2023年5月10日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Basilea Pharmaceutica
入组人数: 300
试验地点: 2
主要终点: Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to >75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Double

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Previous participation in protocol BAP089
•Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease

排除标准

•Female patients who are pregnant or who want to become pregnant
•Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

结局指标

主要结局

Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24

次要结局

Time to respond
at week 12 or 24
Modified total lesion symptom score
Patient's global assessment
Extent of disease

研究者

发起方

Basilea Pharmaceutica

申办方类型

Industry

研究点 (2)

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