NCT02559908已完成不适用
A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 120
- 试验地点
- 20
- 主要终点
- Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
研究概览
简要总结
This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.
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
- •Has chin retrusion.
排除标准
- •Has ever received or is planning to receive permanent facial implants during the study.
- •Has tattoos, piercings, facial hair or scars that would interfere with visual assessments of the chin or jaw.
- •Has dentures or any device covering part of the palate or plans to undergo any dental procedure other than prophylaxis during the study.
- •Has undergone semipermanent dermal filler treatment to the chin or jaw within 36 months or is planning treatment during the study.
- •Has undergone any surgery of the chin or jaw area within 24 months or a planned surgery during the study.
- •Has undergone mesotherapy, cosmetic resurfacing, or botulinum toxin injections within 6 months or a planned treatment during the study.
- •Has experienced trauma to the chin and jaw area within 6 months.
- •Has been previously diagnosed with streptococcal disease.
- •Has a history of anaphylaxis or allergy to lidocaine, hyaluronic acid or streptococcal protein.
- •Has porphyria or untreated epilepsy.
- •Has active autoimmune disease.
- •Has current cutaneous or mucosal inflammatory or infectious processes, abscess, an unhealed wound, or a cancerous or pre-cancerous lesion.
- •Is on a concurrent regimen of lidocaine or structurally-related local anesthetics or is on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism.
- •Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
- •Is on an ongoing regimen of anti-coagulation therapy.
- •Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances known to increase coagulation time (eg, herbal supplements with garlic or gingko biloba) within the past 10 days.
- •Has begun using any over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment or is planning to begin using such products during the study.
研究组 & 干预措施
Treatment Group_VYC-25L
Experimental
VYC-25L injection into the chin and/or jaw areas on Day 1, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable
干预措施: Hyaluronic Acid Injectable Gel (Device)
Control Group_No treatment then VYC-25L
Other
No treatment for 3 months followed by VYC-25L injection into the chin and/or jaw areas, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable.
干预措施: Hyaluronic Acid Injectable Gel (Device)
结局指标
主要结局
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
时间窗: Baseline, Month 3
次要结局
- Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)(Month 3)
- Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS(Month 3)
研究者
研究点 (20)
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