NCT04559984已完成3 期
A Randomized, Multicenter, "No-Treatment" Control Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLUX® Injectable Gel for the Enhancement of the Chin to Correct Moderate to Severe Retrusion in Chinese Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least 18 years of age at the time of signing the ICF
- •Male and female
- •Participants of Chinese descent
- •Participants seeking improvement of chin retrusion
- •Chin retrusion (G-Sn-Pog angle of < 172.5°) based on calculations of facial angle derived from digital images obtained using Canfield imaging equipment and software
- •Has moderate to severe chin retrusion on the CACRS as determined by EI 2D image evaluation
- •Has a reasonable goal for aesthetic improvement in chin retrusion and is able to achieve a 1-point improvement in CACRS score with study intervention in the judgment of TI
- •Capable of giving signed informed consent as described in Appendix 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- •Written informed consent from the participant has been obtained prior to any study-related procedures
- •Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
排除标准
- •History of tendency to develop hypertrophic scarring
- •History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or streptococcal protein
- •Active autoimmune disease
- •Current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion in the chin area (participants with a history of recurrent oral herpes are eligible if prophylactic antiviral/herpes medication is administered for 2 days before study intervention)
- •Impaired cardiac conduction, impaired hepatic function, or impaired renal function according to the judgment of the TI based on medical history, laboratory testing results, and other clinical signs and symptoms
- •Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
- •Permanent dermal filler injected below the subnasale
- •Semi-permanent dermal filler or fat injected below the subnasale within 36 months before enrollment
- •Temporary dermal filler injected below the subnasale within 12 months before enrollment
- •Orthodontics procedures within 12 months before enrollment
- •Botulinum toxin treatment in the chin area within 6 months before enrollment
- •Mesotherapy or cosmetic facial procedures (eg, face-lift, brow lift, facial reconstructive surgery, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) below the subnasale within 6 months before enrollment
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment
- •Abnormal and clinically significant results according to the TI or designee, on hematology, clinical chemistry, or urinalysis
- •Females who are pregnant, nursing, or planning a pregnancy during the study
- •Tattoos, piercings or scars that would interfere with study visual assessments and 3D measurements of chin area in the judgment of TI
- •Trauma to the chin or has residual deficiencies, congenital deformities, or scarring which would impact the trial data evaluation in the judgment of TI
- •Menstruation at the time of study intervention (study intervention may be delayed as necessary to accommodate menstrual period cessation)
- •The participant has a condition or is in a situation which, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
结局指标
主要结局
Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
时间窗: Change from Baseline to Week 24
The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion.
次要结局
- China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24(Week 24)
- Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24(Week 24)
- Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24(Week 24)
- Number of patients experiencing one or more treatment emergent adverse events (TEAEs)(Up to week 52)
研究者
研究点 (8)
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