EUCTR2018-002531-18-FR进行中（未招募）1 期
Topical Everolimus versus placebo for the treatment of facial angiofibromas in patients with tuberous sclerosis complex. A phase II/III, multicentre, randomized, double-blind, placebo-controlled study of 3 doses of topical Everolimus. EVEROST
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •?Male and female subjects > 2 years old.
- •?Subjects meeting the criteria for a definite or possible diagnosis of TSC
- •?Subjects with at least 3 FA, diagnosed by a dermatologist
- •?Women of child-bearing potential with a negative blood pregnancy test at the inclusion.
- •?Subjects or their parents or legal guardians must provide written informed consent prior to participation in the study
- •?Subjects covered by French national health insurance
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 146
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Systemic treatment by sirolimus, everolimus, or any other immunosuppressive drug, within 6 months pre inclusion.
- •?Use of topical tacrolimus or sirolimus on the face, within 6 months pre inclusion.
- •?Destructive treatment (laser therapy, surgery, cryotherapy) of facial angiofibroma, within 6 months pre inclusion.
- •?Current concomitant use of topical treatments that could affect facial erythema (e.g. bromonidine)
- •?Known internal organ involvement requiring systemic mTOR inhibitor in the next 6 months
- •?Immunosuppression (immunosuppressive disease or immunosuppressive treatment)
- •?Known chronic infectious disease
- •?Known hypersensitivity to mTOR inhibitor
- •?Neutropenia < 1000/mm3
- •?Thrombopenia < 75,000/mm3
- •?Chronic renal insufficiency (estimated Glomerular Filtration Rate < 60 mls/min)
- •?Chronic liver disease (SGOT or SGPT > 3 times upper normal limit)
- •?Uncontrolled dyslipidaemia
- •?Uncontrolled diabetes
- •?Breast feeding or pregnant women, or women of childbearing potential without any effective method of contraception during treatment and up to 12 weeks after treatment discontinuation.
- •?Subjects who, in the Investigator’s opinion, are unable or unwilling to comply with the protocol.
研究者
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