NCT01984619已完成不适用
A Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles Utilizing the Iovera With Blunt Tip Cannula Smart Tip
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Wrinkle severity when eyebrows are elevated at 30 days post-treatment.
研究概览
简要总结
To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for the treatment of forehead wrinkles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Females 18-65 years of age.
- •Forehead wrinkle(s) rating of at least 2 in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation of the skin demonstrates a reduction in wrinkle severity.
- •Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5WS.
- •Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
- •Fitzpatrick Skin Type I, II, III, or IV.
- •Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
- •Subject is in good general health, free of any disease state, or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the Investigator's opinion, exposes the subject to an unacceptable risk by study participation.
排除标准
- •Subject has a clotting disorder or coagulopathy that requires use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidigrel, etc.)
- •Subject has used medication or supplements affecting clotting cascade (e.g., aspirin, fish oil, etc.), or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen and naproxen) within seven (7) days prior to administration of the device.
- •Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
- •Subject has undergone another surgical cosmetic procedure or botulinum toxin injection at or above the level of the zygoma (cheekbones) within the past six (6) months prior to administration of the device.
- •Subject has a resting wrinkle score of "3" or higher on the 5WS.
- •Subjects who actively elevate forehead at rest.
- •Subject has been treated with fillers in the temple or forehead area in the time intervals specified prior to the start of their participation in the study.
- •Subject has any of the following:
- •Dermatochalasis with <1mm lid margin when looking straight ahead.
- •Excessive skin laxity.
- •Asymmetry in the upper face.
- •History of facial nerve palsy.
- •Eyebrow or eyelid ptosis.
- •History of neuromuscular disorder.
- •Chronic dry eye symptoms.
- •Allergy or intolerance to local anesthetic agents (e.g., Lidocaine).
- •Use of narcotic medication for a chronic pain condition.
- •Any other clinically significant, in the opinion of the Investigator, local skin condition (e.g., skin infection) at target treatment site that may interfere or be a safety concern.
- •Any physical or psychiatric condition that in the Investigator's opinion would prevent adequate study participation.
- •Chronic medical condition that in the Investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).
- •Diagnosis of:
- •Cryoglobinemia
- •Paroxysmal cold hemoglobinuria
- •Cold Uticaria
- •Raynaud's Disease
- •Open and/or infected wounds
- •Existing neuromuscular disease
- •Fitzpatrick Skin Type V or IV
- •Subject is currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of the iovera° treatment.
- •Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.
结局指标
主要结局
Wrinkle severity when eyebrows are elevated at 30 days post-treatment.
时间窗: 120 Days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural EffusionsMalignant Pleural EffusionsNCT02227732C. R. Bard10
已完成
不适用
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma SubjectsPrimary Open Angle Glaucoma (POAG)NCT01252849Glaukos Corporation119
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIKMyopiaHyperopiaPresbyopiaNCT01977807Technolas Perfect Vision GmbH100
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIKMyopiaHyperopiaNCT02071576Technolas Perfect Vision GmbH42
已完成
不适用
Study to Evaluate the Iovera° Device for Temporary Relief From Knee PainKnee OsteoarthritisNCT02260921Pacira Pharmaceuticals, Inc180