A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 205
- 试验地点
- 30
- 主要终点
- Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
研究概览
简要总结
The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing
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
- 22 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in general good health
- •Participants seeking improvement of temple hollowing
排除标准
- •Temple hollowing due to trauma, congenital malformations, or lipodystrophy
- •Temporomandibular joint dysfunction or any other jaw issues
- •Recurrent temporal headaches such as temporal tendinitis migraine
- •Active autoimmune disease
- •History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
- •Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
- •Fat injection or permanent facial implants anywhere in the face
- •Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
- •Temporary dermal filler injections above the subnasale within 24 months before enrollment
- •Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment
- •Botulinum toxin treatment above the subnasale within 6 months before enrollment
- •Females who are pregnant, nursing, or planning a pregnancy
结局指标
主要结局
Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
时间窗: Baseline, Month 3 (Control Period)
The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Number of Participants With Adverse Events
时间窗: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.
次要结局
- Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3(Month 3 (Control Period))
- Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3(Month 3 (Control Period))
- Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3(Baseline, Month 3 (Control Period))
- Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire(Baseline, Month 3 (Control Period))
