NCT04892407Unknown不适用
A Prospective, Multi-center, Randomized, Controlled, Single-blind Study of the Safety and Effectiveness of Algeness® DF 3.5% Deep Volumizing Filler to Correct Age-related Volume Deficit in the Mid-face
Advanced Aesthetic Technologies, Inc10 个研究点 分布在 7 个国家目标入组 308 人开始时间: 2021年9月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 308
- 试验地点
- 10
- 主要终点
- with ≥ 1 point improvement from baseline on Proprietary Midface Scale, a validated midface volume deficit scale as rated by a live, masked evaluator
研究概览
简要总结
A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The evaluator is blinded as to patient treatment. Patients are also not told what treatment they receive.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 22 years of age.
- •Subject has moderate to severe age-related volume deficit in the midface on both sides of the face as rated on LifeSprout Midface Scale, a proprietary, validated mid-face volume deficit scale
- •Subject willing to abstain from other facial aesthetic procedures in the mid-face through the last study follow-up visit which could interfere with treatment outcomes (e.g., facial fillers, skin laser and radiofrequency therapy such as Thermage, chemical re-surfacing, dermabrasion, Botox injections, aesthetic facial surgery, other facial treatments of the mid-face).
- •Subject willing and able to comply with study follow-up procedures and schedule.
- •Subject willing to provide written informed consent for their participation in the study.
排除标准
- •Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to injection or barrier methods such as condom and spermicide in use at least 14 days prior to injection) or is pregnant, lactating, or plans to become pregnant during the study.
- •Subject has participated in a clinical study in which an investigational device or drug was received in the 30 days prior to screening or plans to enroll in such a study during the course of the current study.
- •Subject is an employee or direct relative of an employee of the investigational site or Sponsor.
- •Subject who has received surgery in the mid-face (including mesh, or threads), or has plans to during the study.
- •Subject has a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk (e.g., uncontrolled diabetes, autoimmune pathology, cardiac pathologies).
- •Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
- •Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
- •Subject has a history of precancerous lesions/skin malignancies.
- •Subject has had an active skin disease within the past 6 months.
- •Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology on the mid-face.
- •Subject has facial hair in the mid-face that they are unwilling to remove for study assessments.
- •Subject is predisposed to keloidosis or hypertrophic scarring.
- •Subject has a known history of hyper- or hypo-pigmentation in the mid-face.
- •Subject has known allergy to agarose gel, algae, phosphate buffered saline, hyaluronic acid, gram positive bacterial proteins, streptococcal protein or lidocaine.
- •Subject has a known bleeding disorder.
- •Subject has received within the past week or plans to receive with 1 week before or up to 1 month after any treatment high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets, thrombolytics, or any other medication that could increase the risk of bleeding.
- •Subject has received within the past 3 months or plans to receive during the study chemotherapy agents, immunosuppressive medications, or systemic corticosteroids (inhaled steroids are acceptable).
- •Subject has received within the past 12 months or plans to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., hyaluronic acid, CaHA)
- •Subject has received within the past 12 months or plans to receive during the study neurotoxin on the face below the orbital rim (forehead is acceptable).
- •Subject has received at any time or plans to receive during the study a permanent filler (e.g., polylactic acid, PMMA, silicone) on the face.
- •Subject has received within the past 6 months or plans to receive during the study dermal resurfacing procedures or non-invasive skin tightening on the face.
- •Subject has received in the past 4 weeks or plans to receive during the study prescription facial wrinkle therapies (RENOVA), topical steroids, skin irritating topical preparations, or self-tanning agents on the face.
- •Subject has a known history of or plans during the study rapid weight loss/gain (5% of body weight).
结局指标
主要结局
with ≥ 1 point improvement from baseline on Proprietary Midface Scale, a validated midface volume deficit scale as rated by a live, masked evaluator
时间窗: 6 month
Statistical non inferiority of Study Product to Control by live Masked Evaluator of Subjects showing atleast a 1 point improvement. LifeSprout Midface Scale (0-4 with 0 being best and 4 being the worst/most extreme)
次要结局
- 1+ grade Improvement on Midface Scale Live Masked Evaluator All timepoints(1, 3, 9, 12, 18, 24 months)
研究者
研究点 (10)
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