NCT04078555招募中2 期
A Randomized, Double-Blind, Placebo-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Venous Leg Ulcer (VLU)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of complete ulcer closure
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU). Subjects will be recruited from multiple sites in Taiwan. The treatment period will be 84 days with another 84-day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With either gender aged at least 20 years old
- •With venous reflux >0.1 sec measured by duplex ultrasound imaging dated within 6 months prior to the Screening visit
- •With at least one venous ulcer on the lower leg (knee to ankle inclusive) and not healing for at least 4 weeks. The ulcer with the largest surface area will be selected as target ulcer. If two or more ulcers have the largest size, the one with the longest duration will be selected
- •With the target ulcer size of 2 cm2 to 50 cm2
- •Target VLU involves a full thickness skin loss, but without exposure of tendon, muscle, or bone
- •Target VLU should be free of any necrosis or infection in any soft tissue and bone tissue
- •Able to tolerate compression therapy
- •Subject has signed the written informed consent form
排除标准
- •Target VLU With active cellulitis or osteomyelitis
- •With target ulcer size decreased by at least 30% after 2 weeks of standard care
- •With poor nutritional status (albumin < 2g/dl), poor diabetic control (HbA1c > 12%), a leukocyte counts < 2,000/mm3, abnormal liver function (AST, ALT>3 × upper limit of normal range) tests within 14 days prior to Screening visit or 28 days prior to Randomization visit
- •Requiring treatment with chemotherapeutic agents
- •With known or suspected hypersensitivity to any ingredients of IP and matched vehicle
- •With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to Screening visit
- •(1) Female subject of childbearing potential who:
- •is lactating; or
- •has positive pregnancy test result at eligibility checking; or
- •refuses to adopt at least one form of birth control from signing informed consent to the end of study
- •Acceptable forms include:
- •Established use of oral, injected or implanted hormonal methods of contraception. Placement of an intrauterine device (IUD) or intrauterine system (IUS).Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)
- •7(2) Male subject with female spouse/partners who are of childbearing potential refuses to adopt at least one form of birth control (at least one of which must be a barrier method) from signing informed consent to the end of study)
- •With ankle brachial index (ABI) < 0.6
- •Enrollment in any investigational drug trial within 4 weeks before entering this study
- •With any condition judged by the investigator that entering the trial may be detrimental to the subject
研究组 & 干预措施
ENERGI-F703 GEL
Experimental
topical application on target venous leg ulcer, twice daily
干预措施: ENERGI-F703 GEL (Drug)
ENERGI-F703 GEL matched vehicle
Placebo Comparator
topical application on target venous leg ulcer, twice daily
干预措施: ENERGI-F703 GEL matched vehicle (Drug)
结局指标
主要结局
Incidence of complete ulcer closure
时间窗: Day -21 to Day 99
Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.
次要结局
- The accumulated confirmed target ulcer closure incidence at each of the post-treatment visit(Day -21 to Day 85)
- Incidence of vital signs abnormalities(Day -21 to Day 169)
- Incidence of physical examination abnormalities(Day -21 to Day 169)
- Percentage change in target ulcer area from baseline to each post-treatment visit(Day -21 to Day 85)
- Incidence of laboratory examination results abnormalities(Day -21 to Day 169)
- Time-to-Complete ulcer closure of target ulcer(Day -21 to Day 99)
- Incidence of AEs and SAEs(Day -21 to Day 169)
研究者
研究点 (1)
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