A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
研究概览
简要总结
This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •To qualify for the study a subject must:
- •Be able to provide voluntary written informed consent prior to the initiation of any study-specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •Have participated in and completed both studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-
- •Be willing and able to comply with all protocol required visits and assessments.
排除标准
- •Subjects will be ineligible for participation in this study if the subject:
- •Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-
- •Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
- •Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study.
- •Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision).
- •Any investigational treatment for EFP/cellulite.
- •Endermologie® or similar treatments.
- •Massage therapy.
- •Creams (eg, Celluvera™, TriLastin®).
- •Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.
结局指标
主要结局
Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
时间窗: Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
Change from baseline (pre-dose, Day 1) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe
Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
时间窗: Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
Change from baseline (pre-dose, Day 1) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe
Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
时间窗: Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study
Change from reference time point (Day 71) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe
Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
时间窗: Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study
Change from reference time point (Day 71) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe
次要结局
未报告次要终点