Multicenter, Evaluator-Blinded, Randomized, No-Treatment Controlled Study of the Effectiveness and Safety of JUVÉDERM® VOLITE™ Injectable Gel for the Improvement in Skin Quality
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) Live Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS)
研究概览
简要总结
Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in the treatment of fine lines and improving skin quality.
VOLITE is an investigational device being developed for improving skin quality. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of skin quality, especially hydration and radiance, in the treatment area will be enrolled. Around 135 participants will be enrolled in the study at approximately 6 sites in China.
Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick skin types II-IV
- •Participants' FACE-Q Satisfaction with Skin Scale scores must meet the following criteria:
- •Participants must have FACE-Q Satisfaction with Skin Scale sum of raw scores of 39 or less
- •Participants must score "Very Dissatisfied" or "Somewhat Dissatisfied" on the following two questions:
- •How hydrated your facial skin looks?
- •How radiant your facial skin looks?
排除标准
- •Any skin condition in the face area that might not be suitable for injection
- •Uncontrolled systemic disease
- •History of anaphylactic shock, or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study
- •Active autoimmune disease
- •Tendency to develop hypertrophic scarring
- •Currently undergoing chemotherapy/radiotherapy
- •Is undergoing orthodontia before enrollment or is planning to undergo it during the study
研究组 & 干预措施
JUVÉDERM® VOLITE™
Participants in the treatment group will receive a single dose at the study initiation. Participants are eligible for touch up treatment.
干预措施: JUVÉDERM® VOLITE™ (Device)
Control - No Treatment
Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive the treatment.
干预措施: JUVÉDERM® VOLITE™ (Device)
Control - No Treatment
Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive the treatment.
干预措施: Control (Other)
结局指标
主要结局
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) Live Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS)
时间窗: Month 2
A "responder" is a participant who shows improvement in the overall aesthetic assessment on the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'.
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately Month 12
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in participants, users, or other persons, whether or not related to the investigational medical device, and whether anticipated or unanticipated.
次要结局
- Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area using GAIS(Month 2)
- Percentage of Participants Achieving "Responder" Status for Treating Investigator's (TI) Assessment of Global Aesthetic Improvement of Skin Quality on the Treatment Area using GAIS(Month 2)
- Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale(Month 2)
- Percentage of Participants with Responder Status based on EI's Live Assessments of Hydration Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Hydration(Month 2)
- Percentage of Participants with Responder Status based on EI's Live Assessments of Radiance Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Radiance(Month 2)
- Change from Baseline in Treatment Area Skin Elasticity Measurement(Month 2)
- Change from Baseline in Treatment Area Skin Hydration Measurement(Month 2)