NCT02942160已完成2 期
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Endo Pharmaceuticals28 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2016年10月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 259
- 试验地点
- 28
- 主要终点
- Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
研究概览
简要总结
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for Observation Phase:
- •Voluntarily sign and date an informed consent agreement
- •Have participated in and completed the double-blind study EN3835-201
- •Be willing to apply sunscreen to any treated quadrant before each exposure to sun
- •Inclusion Criteria for Treatment Phase:
- •Voluntarily sign and date an informed consent agreement
- •Have participated in and completed the double-blind study EN3835-201
- •Be willing to apply sunscreen to any treated quadrant before each exposure to sun
- •Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13
- •Be judged to be in good health
- •Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal
排除标准
- •for Observation Phase:
- •Exclusion Criteria for Treatment Phase:
- •Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks
- •Is presently nursing a baby or providing breast milk for a baby
- •Intends to become pregnant during the study
- •Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication
- •History of stroke or bleeding
结局指标
主要结局
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
时间窗: Day 180 to Day 360
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.
次要结局
- Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase(Day 180 to Day 360)
- Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase(Day 540 to Day 720)
- Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase(Day 540 to Day 720)
- CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase(Baseline (in EN3835-201 Study) to Observation Day 360)
- CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment(Day 22 to Day 360)
- PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment(Day 22 to Day 360)
- Change From Baseline on the Hexsel CSS Total Score During the Observation Phase(Baseline (in EN3835-201 Study) to Day 360)
- Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits(Day 540 to Day 720)
- Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment(Baseline - Day 360)
- Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase(Day 360)
- Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment(Day 71 - Day 360)
- Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360(Day 360)
- Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment(Day 71 - Day 360)
- Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360(Day 360)
- Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment(Day 71 - Day 360)
研究者
研究点 (28)
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