EUCTR2014-002288-14-DE进行中（未招募）1 期
A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study
Scioderm, An Amicus Therapeutics Company0 个研究点目标入组 150 人开始时间: 2014年12月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- 性别
- All
入选标准
- •1. Informed Consent form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient.
- •2. Patient (or caretaker) must be willing to comply with all protocol requirements.
- •3. Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.
- •4. Patient must have 1 target wound (size 10 to 50 cm2).
- •5. Patients 1 month and older.
- •6. Target wound must be present for 21 days or more.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who do not meet the entry criteria outlined above.
- •2. Selected target wound cannot have clinical evidence of local infection.
- •3. Use of any investigational drug within the 30 days before enrollment.
- •4. Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
- •5. Use of systemic or topical steroidal therapy within the 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed)
- •6. Use of systemic antibiotics within the 7 days before enrollment.
- •7. Current or former malignancy.
- •8. Arterial or venous disorder resulting in ulcerated lesions.
- •9.Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at screening and every 30 days until the final visit for female patients of childbearing potential)
- •10. Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.
研究者
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