NCT04677712已完成4 期
MOBI: A Phase 4, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite in Adult Females
Endo Pharmaceuticals8 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年12月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
研究概览
简要总结
This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks.
详细描述
CCH-aaes is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. Since bruising may be bothersome, this study will investigate treatments that may mitigate bruising after treatment of cellulite in the buttocks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 with:
- •Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3 (moderate) as reported by the Investigator, and
- •Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of laxity, flaccidity, or sagging skin" score of 0 (absence of laxity, flaccidity, or sagging skin) or 1 (slightly draped appearance).
- •Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m^2).
- •Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study).
- •Be judged to be in good health.
- •Be willing and able to cooperate with the requirements of the study.
排除标准
- •Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.
- •Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
- •Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.
- •Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment.
- •Antiplatelet medication (clopidogrel [Plavix®] including aspirin at any dose within 14 days of treatment.
- •Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.
- •Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.
- •Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment.
- •Antibiotics, such as penicillin and cephalosporin within 48 hours of treatment.
- •Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
- •Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.
- •Intends to initiate an intensive sport or exercise program during the study.
- •Tanning or use of tanning agents.
- •Intends to engage in strenuous activity within 48 hours after the first injection of CCH-aaes.
- •Has received an investigational drug or treatment within 30 days prior to injection of CCH-aaes.
- •Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH-aaes.
- •Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (that is, arnica patches, INhance Post-injection Serum).
- •Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH-aaes in a previous investigational study for cellulite.
- •For participants allocated to PDL treatment Participants will be excluded from PDL treatment if they have any contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of CCH-aaes treatment.
研究组 & 干预措施
Cohort 1: CCH-aaes
Active Comparator
CCH-aaes was administered without mitigation treatment (control group).
干预措施: CCH-aaes (Drug)
Cohort 2: CCH-aaes + Compression Garment
Active Comparator
CCH-aaes was administered with compression garment.
干预措施: Compression (Other)
Cohort 3: CCH-aaes + Instant Cold Packs
Active Comparator
CCH-aaes was administered with instant cold packs.
干预措施: Cold Packs (Other)
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
Active Comparator
CCH-aaes was administered with arnica gel patches (OcuMend).
干预措施: Arnica Gel (Drug)
Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology®
Active Comparator
CCH-aaes was administered with INhance Post-Injection Serum with TriHex Technology®
干预措施: INhance® (Drug)
Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL)
Active Comparator
CCH-aaes was administered with PDL.
干预措施: PDL (Other)
结局指标
主要结局
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
时间窗: Day 4 (3 days after CCH-aaes injection)
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
次要结局
- Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7(Day 7)
- The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14(Day 14)
- Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS)(Days 4 and 7)
- Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)(Days 4 and 7)
- Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4(Day 4)
- The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22(Day 22)
- Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71(Day 71)
研究者
研究点 (8)
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