A Prospective, Multi-center, Randomized, No-Treatment Controlled, Evaluator-Blinded, Superiority Clinical Investigation of the Safety and Effectiveness of TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Teoxane SA
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- TIOHS = Teoxane Infraorbital Hollows Scale (grade 0 = no visible infraorbital hollow ; grade 4 = very severe infraorbital hollow)
研究概览
简要总结
This is a prospective, multi-center, randomized, no-treatment controlled, evaluator-blinded clinical investigation to identify whether TEOSYAL RHA® 1 is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in Chinese adults.
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 3:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL RHA® 1 in both Infraorbital Hollows (IOH), whereas subjects assigned to the control group will not receive any treatment.
The subjects in the treatment group will be treated with RHA1 for the treatment of moderate to severe tissue volume deficiencies in the infraorbital region on Day 0.
All treated subjects will return to the site at 2, 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessments. Each treated subjects will receive a safety phone call 3 days after the initial treatment at baseline, and after the touch-up treatment, if any. Their participation in the trial ends after the completion of the follow up period.
All non treated subjects (control group) will return to the site at 2, 4, and 12 weeks after randomization for effectiveness and safety assessments. Their participation in the investigation ends after the effectiveness and safety assessments at 12 weeks after randomization.
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)
盲法说明
Blinded-Live Evaluator (BLE)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese male and female, 18 years of age or older.
- •Subject seeking treatment of moderate to severe tissue volume deficiencies in the infraorbital region.
- •Subjects with a grade of 2 (moderate) or 3 (severe) on the TIOHS for both eyes, as determined on assessments by the Treating Investigator (TI) and BLE.
- •Subject willing to abstain from all other facial aesthetic procedures/therapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, Intense Pulsed Light [IPL], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.
- •Woman of childbearing potential agree to use contraception during the investigation.
- •Subject understands and is able to follow instructions and complete all scheduled visits.
- •Subjects who voluntarily decided to participate in the investigation and signed the informed consent.
排除标准
- •Known hypersensitivity or previous allergic reaction to any component of the study device.
- •Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- •History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
- •History of connective tissue disease.
- •Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- •Subjects who participated in other clinical investigation within 30 days, or in an exclusion period from a previous study.
结局指标
主要结局
TIOHS = Teoxane Infraorbital Hollows Scale (grade 0 = no visible infraorbital hollow ; grade 4 = very severe infraorbital hollow)
时间窗: 12 weeks after the last treatment for the treatment group / 12 weeks after randomization for the control group
Proportion of responders, defined by at least 1-grade improvement in both eyes from baseline 5-point TIOHS, as assessed by the BLE at 12 weeks after treatment.
次要结局
未报告次要终点