NCT06336785已完成4 期
A Prospective Clinical Trial Evaluating the "Kiss and Smile HIT" (Holistic Individualized Treatment) Algorithm
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Global Aesthetic Improvement Scale (GAIS)
研究概览
简要总结
The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.
The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must voluntarily sign and date an informed consent, including the photography addendum allowing unrestricted use of photographs for the use of marketing and educational purposes, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
- •Subjects must at least 18 years old
- •Male or female
- •Subjects must be willing and able to comply with procedures required in the protocol
- •Subjects must be in good health as per investigator's judgment based on medical history
- •Female subjects of child-bearing potential must have a negative urine pregnancy test prior to any dose of study product
- •Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Baseline through at least 30 days after the last dose or until the end of study, whichever is longer. Female subjects of nonchildbearing potential do not need to use birth control.
排除标准
- •Uncontrolled systemic disease
- •Subjects do not present with or have a history of any medical condition that may place the subject at increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including:
- •Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- •History of facial nerve palsy
- •Infection or dermatological condition at the treatment injection sites
- •Marked facial dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin
- •History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study medical device
- •History of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients)
- •Subject has tattoos, jewelry, or clothing which obscure temporal region and cannot be removed
- •Subject has anticipated need for surgery or overnight hospitalization during the study.
- •History of surgical procedures in the face including any lifting procedure (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
- •Subject has a history of facial treatment with semi- permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
- •Subjects is presenting with porphyria
- •Subjects has present with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites
- •Subject has bleeding disorders or take thrombolytics or anticoagulants
- •Subjects has had known active COVID infection within 30 days of treatment
- •Female subjects that are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
- •Subjects has been treated with any investigational drug within 30 days prior to the first dose of study drug or is currently enrolled in another clinical study.
- •Subject must take immunosuppressant medication
结局指标
主要结局
Global Aesthetic Improvement Scale (GAIS)
时间窗: Baseline to Week 2, Week 4, Week 8, Week 20
Frequency of subjects having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), as graded by a blinded evaluator. Grading value varies from worse (grading of -1) to very much improved (grading of 3).
次要结局
未报告次要终点
研究者
研究点 (2)
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