A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 168
- 试验地点
- 9
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The objectives of this study are to evaluate the safety and effectiveness of JUVÉDERM® VOLUMA® with Lidocaine injectable gel in adult Chinese population 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 or over, at the time of signing the ICF
- •Participants seeking improvement of temple hollowing
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the 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
- •Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all participant self-assessments)
排除标准
- •Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired
- •Has experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring
- •Temporal arteritis or history of temporal arteritis
- •Temporomandibular joint dysfunction or any other jaw issues
- •Recurrent temporal headaches such as temporal tendinitis migraine
- •Active or recurrent inflammation or infection in either eye
- •Tendency to develop hypertrophic scarring
- •Active autoimmune disease
- •History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
- •Current cutaneous or mucosal inflammatory or infectious processes (e.g. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, above the subnasal
- •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 12 months before enrollment
- •Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment (examples of mesotherapy or cosmetic facial procedures are laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures.
- •Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment
- •Botulinum toxin treatment above the subnasale within 6 months before enrollment
- •Has braces or other orthodontics
- •Not eligible for this study if participants have begun using any new over the counter or prescription oral or tropical, anti-wrinkle products above the subnasale within 30 days before enrollment. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study
- •Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
- •Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple
- •Females who are pregnant, nursing, or planning a pregnancy
- •Plans a significant weight change (more than 10% of body weight) during the study
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Up to 14 Months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS)
时间窗: Change from Baseline to Month 6
The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
次要结局
- Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6(Change from Baseline to Month 6)
- Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6(Change from baseline to Month 6)
- Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)(Month 6)
- Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)(Month 6)