A prospective, single arm, investigator initiated clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler(JEUNESSO 20L) in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- (Pre-operative, Day-0, 3 Month, 6 Month and
研究概览
简要总结
this is prospective, single arm, investigator initiated clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler(JEUNESSO 20L) in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement.
Primary Objective: 1) To Assess the safety and performance of Crosslinked HA for cheekbone Augmentation, nasolabial fold treatment and Lip Enhancement 2) Incidence of all adverse events at 6 and 12 months and any systemic adverse events.
Secondary Objective: 1) Assess dermal filler success in overall face improvement.2) Evaluate efficacy of Cross-linked HA in Cheek Bone Augmentation, nasolabial folds and Lip Enhancement3) Evaluate proportion of population reporting with dermal filler’s adverse effect during the course of the study.4) Evaluate long-term safety up to 12 Months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patient must be ≥ 18 and ≤ 75 years of age.
- •The patient is willing and able to comply with the study protocol.
- •The patient is seeking soft tissue augmentation treatment on the face.
- •The patient agrees to follow-up examinations out to 12 months post final treatment.
- •The patient has a pre-treatment Wrinkle Severity Rating Scale (WSRS) ≥ 2 for bilateral Nasolabial Fold (NLF) to be treated.
排除标准
- •At risk in term of precautions, warnings and contraindication referred in the package insert of the study dermal filler
- •Who underwent previous injection of permanent filler in the injected area
- •Pregnant/lactating women
- •Participation in any other Clinical trial.
- •Subjects who have an allergy to lidocaine, prilocaine or other amide-type anesthetic
- •Had a chemical peel at the Nasolabial Fold (NLF) area within 4 weeks prior to study entry.
- •In addition, subjects were restricted from undergoing chemical peels at the Nasolabial Fold (NLF) area for the duration of the study
- •Had a history of hypo- or hyperpigmentation of the skin.
- •Inolerance to antibiotics or corticosteroids.
- •Had any infection, unhealed wound, or active inflammatory process (e.g., skin eruptions such as cysts, pimples, rashes, or hives) at the injection site(s).
- •A known history of keloids or bleeding disorders.
- •Leukoderma (Vitiligo) or a family history of leukoderma or other pigmentary disorders.
- •Severe physical, neurological or mental disease.
结局指标
主要结局
(Pre-operative, Day-0, 3 Month, 6 Month and
时间窗: (Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
12 Months Post-Operative Follow-up)
时间窗: (Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
A. The primary efficacy endpoint is responder rate in GAIS
时间窗: (Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
Score from Day 0 to 12 Months and study of the safety
时间窗: (Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
and severity of adverse events (AEs)
时间窗: (Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
次要结局
- A. To evaluate the Cheek bone Augmentation, the(improvement in the Nasolabial fold and Evaluate Lip)