A Multicenter, Randomized, Subject & Evaluator-blinded, Matched Pairs, Non-inferiority, Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With Rejuviel V® With Lidocaine as Compared to JUVEDERM® VOLUMA® With Lidocaine for Temporary Restoration of Mid-face Volume
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Percentage improvement in mid-face volume
研究概览
简要总结
The purpose is to evaluate the efficacy and confirm the safety of Rejeunesse Contour® with Lidocaine compared to Juvederm® Voluma® with Lidocaine for the temporary improvement of mid-face volume (including the cheekbone area, the anterior-medial cheek, and the area below the cheekbone).
The investigational medical device will be administered a total of once during the entire clinical trial period (or up to twice if additional treatment is required). After the administration, photographs of the application site and evaluations using the Mid-Face Volume Deficit Scale (MFVDS) will be conducted at 4 weeks, 12 weeks, 24 weeks, and 48 weeks. Satisfaction with mid-face volume improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS). Additionally, changes in concomitant medications/treatments and adverse events will be reviewed in comparison to the previous visit.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Korean men and women aged ≥30 years and ≤65 years at the time of informed consent.
- •At screening, subjects with a score of 3 (moderate) or higher on the Mid Face Volume Deficit Scale (MFVDS), as assessed by independent on-site evaluators, with symmetrical deficits in both mid-face regions including the zygomatic area, anterior medial cheek, and subzygomatic area.
- •Subjects who agree not to undergo any other procedures (e.g., filler injections other than the investigational medical device, laser treatment, chemical peeling, botulinum toxin, or facial plastic surgery) during the course of the clinical trial.
- •Subjects who are able to understand and follow instructions and participate throughout the entire duration of the clinical trial.
- •Subjects who voluntarily provide written informed consent to participate in the clinical trial.
排除标准
- •History of anaphylaxis or severe allergic reactions requiring treatment.
- •History of hypertrophic scars, keloids, or post-inflammatory hyperpigmentation.
- •Use of anticoagulants (e.g., warfarin), antiplatelets, thrombolytics, immunosuppressants, or NSAIDs within 2 weeks prior to screening, or intake of other agents that may prolong coagulation time (e.g., vitamin E, garlic, ginkgo); Low-dose aspirin ≤300 mg/day permitted; participation allowed after ≥5 half-lives washout of the active compound.
- •Use of topical facial medications (steroids, retinoids; excluding cosmetics) within 4 weeks prior to screening or planned during the study.
- •Known hypersensitivity to investigational device components (sodium hyaluronate, lidocaine, lidocaine hydrochloride hydrate) or to amide-type local anesthetics (lidocaine, prilocaine, etc.).
- •History of autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, autoimmune hemolytic disease).
- •History of sarcoidosis, granulomatous disease, or Osler's endocarditis.
- •Active skin disease, inflammation, infection, scar, or wound at the treatment area.
- •History or presence of herpetic eruption.
- •Bleeding disorders.
- •Severe hepatic dysfunction (ALT or AST >3 × ULN).
- •Coagulation abnormalities (INR >1.5 × ULN).
- •Prior or planned facial procedures/surgeries that may affect outcomes; permanent implants (e.g., PMMA, silicone, Gore-Tex) in treatment area.
- •History of malignancy within the past 5 years.
- •Drug or alcohol abuse.
- •Heavy smoking (>20 cigarettes/day).
- •Requirement for continuous immunosuppressive therapy during the study.
- •Active inflammatory conditions requiring systemic anti-inflammatory treatment (including streptococcal diseases).
- •Thin skin in the mid-face or fluid retention tendency in lower eyelids/infraorbital fat pads.
- •Use of wrinkle-preventive medical devices or drugs in the mid-face within 3 months prior to screening, or planned during the study.
- •Untreated epilepsy.
- •Porphyria.
- •Use of another investigational medical device or drug within 3 months prior to screening.
- •Female subjects of childbearing potential who are unwilling to use medically acceptable contraception during the study, or who are pregnant, breastfeeding, or planning pregnancy.
研究组 & 干预措施
Rejuviel V with lidocaine
Single injection and optional touch up injection in Midface
干预措施: Rejuviel V® with lidocaine (Device)
JUVEDERM® VOLUMA® with lidocaine
Single injection and optional touch up injection in Midface
干预措施: JUVEDERM® VOLUMA® with lidocaine (Device)
结局指标
主要结局
Percentage improvement in mid-face volume
时间窗: at Weeks 24 after the final administration
Percentage improvement in mid-face volume at Weeks 24 after the final administration of the investigational medical device, as assessed by independent photo evaluators compared with baseline
次要结局
未报告次要终点