A prospective, single arm, investigator initiated clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler (JEUNESSO 30L) 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
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint is responder rate in GAIS Score from Day 0 to 12 Months and study of the safety and severity of adverse events (AEs).
研究概览
简要总结
This is a prospective, single arm, investigator initiated clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler (JEUNESSO 30L) in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement.
Investigational product to be used is Juenesso 30L is a transparent gel made up of novel cross-linked hyaluronic acid with concentration of 30 mg/ml which is already approved in INDIA.
Primary objective:
-
To assess the safety and performance of Crosslinked HA for cheekbone Augmentation, nasolabial fold treatment and Lip Enhancement
-
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 Enhancement
3.Evaluate proportion of population reporting with dermal filler’s adverse effect and during the course of the study.
4. Evaluate long-term safety up to 12 Months
Following endpoints will measured during the trial:
Primary Endpoint:
- The primary efficacy endpoint is responder rate in GAIS Score from Day 0 to 12 Months and study of the safety and severity of adverse events (AEs)
Secondary Endpoint:
1.To evaluate the Cheek bone Augmentation, the improvement in the Nasolabial fold and Evaluate Lip Enhancement from Day 0 to 3, 6 and 12 Months
2. To access Global Aesthetic Improvement scale from Day 0 to 3, 6 and 12 Months
3.To access the frequency and severity of adverse events (AEs) documented at each study visit.
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.
- •2.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 Score (WSS) ≥ 2 for bilateral NLF to be treated.
排除标准
- •At risk in term of precautions, warnings and contra-indication 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 NLF area within 4 weeks prior to study entry.
- •In addition, subjects were restricted from undergoing chemical peels at the NLF area for the duration of the study.
- •Had any treatment with Botox® injections:
- •In the upper 1/3 of the face within 2 weeks prior to entry into the study, or
- •In the lower 2/3 of the face within 24 weeks prior to entry.
- •In addition, subjects were restricted from receiving Botox injections in the face for the duration of the study.
- •Had a history of hypo- or hyperpigmentation of the skin.
- •Tolerance 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
The primary efficacy endpoint is responder rate in GAIS Score from Day 0 to 12 Months and study of the safety and severity of adverse events (AEs).
时间窗: Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up
Time points:(Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up)
时间窗: Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up
次要结局
- 1.To evaluate the Cheek bone Augmentation, the improvement in the Nasolabial fold and Evaluate Lip Enhancement from Day 0 to 3, 6 and 12 Months(2. To access Global Aesthetic Improvement scale from Day 0 to 3, 6 and 12 Months)