A Multicenter, Evaluator and Subject-blinded, Randomized, Comparator-controlled, Parallel-design Study to Evaluate the Safety and Effectiveness of NOA VOLUME Compared to JUVÉDERM® VOLUMA® XC for Improvement of Mid-face Volume
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 231
- 试验地点
- 15
- 主要终点
- Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)
研究概览
简要总结
Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) injectable gel formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC).
NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. Participants will receive either NOA VOLUME or VOLUMA XC. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States.
Participants will receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 and will be followed up for up to 31 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment.
- •Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.
排除标准
- •Significant skin laxity in the midface in the opinion of the TI.
- •Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.
- •Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.
研究组 & 干预措施
Cohort 1: NOA VOLUME
Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.
干预措施: NOA VOLUME (Device)
Cohort 2: VOLUMA XC
Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.
干预措施: VOLUMA XC (Device)
Cohort 1: VOLUMA XC
Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.
干预措施: VOLUMA XC (Device)
Cohort 2: NOA VOLUME
Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.
干预措施: NOA VOLUME (Device)
结局指标
主要结局
Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)
时间窗: Month 6
A "responder" is defined as a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None/Minimal to 5 = Severe).
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately Month 31
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Percentage of Participants Achieving "Responder" Status Based on Participant's Assessments of Global Aesthetic Improvement in the Treatment Area Using Global Aesthetic Improvement Scale (GAIS)(Month 6)
- Percentage of Participants Achieving "Responder" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the GAIS(Month 6)
- Change from Baseline in the Overall Score of FACE-Q Satisfaction with Cheeks(Month 6)