Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Physician global assessment of severity (PGAS)
研究概览
简要总结
This is an open label-pilot study to assess the efficacy and safety of a novel cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often times, these children have difficulty in finding easily applied treatments to make their psoriasiform and ichthyotic plaques more manageable. We propose the use of a cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it will lead to regression of involved areas and decreased erythema and warty-like appearance of the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for a 12 month study with a total of 5 visits and 5 phone calls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent form signed by the subject or subject's legal representative; also, if the subject is under the age of majority but capable of providing assent, signed assent from the subject.
- •Diagnosis of a syndromic ichthyoses (verified by Dr Amy S. Paller).
- •Children and adults 12 months of age and above
排除标准
- •Use of any investigational drug within the 30 days before enrollment.
- •Current malignancy.
- •Pregnancy or breastfeeding during the study. (All female subjects of childbearing potential will be assessed for pregnancy at all visits.)
研究组 & 干预措施
Lovastatin solution
All patients will receive lovastatin solution
干预措施: Lovastatin (Drug)
结局指标
主要结局
Physician global assessment of severity (PGAS)
时间窗: 12 months
Difference in physician global assessment of severity at baseline compared to month 12
次要结局
- Total body surface area (TBSA)(12 months)
研究者
Amy Paller
Professor and Chair of Department of Dermatology, Professor of Pediatrics
Northwestern University