NCT04209530终止2 期
A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology
Endo Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The Change From Baseline (Screening) in PR-PCSS
研究概览
简要总结
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have both buttocks or both posterolateral thighs with:
- •A score of 3 or 4 (moderate or severe) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
- •A Hexsel Cellulite Severity Scale (CSS) Subsection A "Number of Evident Depressions" score of >0, and Subsection B "Depth of Depressions" score of 2 )medium depth depression) or 3 (deep depressions)..
- •Have a minimum of 2 well defined and isolated cellulite dimples.
- •Be willing to apply sunscreen to the treatment area before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 251/Early Termination Visit).
- •Be judged to be in good health.
- •Have a negative pregnancy test.
- •Be willing and able to cooperate with the requirements of the study.
排除标准
- •Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
- •Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
- •Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
- •Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
- •Requires anticoagulant or antiplatelet medication during the study.
- •Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
- •Has used any form of artificial tanning (sprays, lotions, tanning booth, etc) within the 30 days prior to the first dose of study treatment or plans to use any form of artificial tanning during the study (through the Day 251/Early Termination Visit).
- •Has a positive HIV test and/or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) test at screening.
- •Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment.
- •Has a history of keloids, hypertrophied scars, and/or other complications following biopsy.
- •Has any contraindications for MRI(implant containing metal, internal metallic object, permanent cosmetics/make-up, claustrophobia, syncope, low blood pressure, epilepsy, asthma, sickle cell disease) that restricts study participation.
- •Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.
- •Has previously received treatment with CCH in this clinical study.
- •Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
- •Is pregnant and/or is providing breast milk or plans to become pregnant and/or to provide breast milk during the course of the study.
- •Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
研究组 & 干预措施
Buttock & Posterolateral Thigh
Experimental
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
干预措施: EN3835 (Drug)
结局指标
主要结局
The Change From Baseline (Screening) in PR-PCSS
时间窗: Day 71
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective
次要结局
- MRI Before and After CCH Treatment(Day 71)
- Histopathology Before and After CCH Treatment(Day 71)
- The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS)(Day 22, Day 43 and Day 71)
- The Change From Baseline (Screening) in CR-PCSS(Day 22, Day 43 and Day 71)
研究者
研究点 (1)
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