Evaluation of Changes in Gene Expression Following Ultherapy® Treatment

Ulthera, Inc4 个研究点分布在 1 个国家目标入组 16 人开始时间: 2015年5月1日最近更新: 2019年2月20日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方: Ulthera, Inc
入组人数: 16
试验地点: 4
主要终点: Changes in Gene Expression in Facial Skin Tissue Treated With Ultherapy Compared to Control (Untreated) Tissue Through Microarray Profiling

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Up to 25 subjects will be enrolled and randomized. Randomized subjects will receive one single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's scheduled facelift procedure, resected tissue will be obtained for analysis.

详细描述

This is a prospective, multi-center, pilot clinical trial to evaluate the molecular changes following an Ultherapy® treatment. Subjects will be randomized to one of five treatment groups and, based on study group assignment, will receive one single-side Ultherapy® treatment at varying timepoints prior to an already planned facelift procedure. Treatment will be delivered to the pre-auricular region on one side of the face; the contralateral side will serve as control. During an already planned facelift procedure, treated and non-treated resected tissue will be obtained for analysis.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 45 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female, age 45 to 70 years.
•Subject in good health.
•Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
•Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
•Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study.
•Absence of physical or psychological conditions unacceptable to the investigator.
•Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other Non-Steroidal Anti-Inflammatory Drug (NSAID) prior to study treatment and chronic use during the entire post-treatment study period.
•Willingness and ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to performance of any study-related procedure.

排除标准

•Presence of an active systemic or local skin disease that may affect wound healing.
•Severe solar elastosis.
•Significant scarring in the area(s) to be treated that would interfere with assessing results.
•Open wounds or lesions in the area(s) to be treated.
•Severe or cystic acne on the area(s) to be treated.
•Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
•Inability to understand the protocol or to give informed consent.
•Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
•Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
•BMI equal to or greater than
•History of chronic drug or alcohol abuse.
•History of autoimmune disease.
•Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
•Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
•Concurrent enrollment in any study involving the use of investigational devices or drugs.
•Current smoker or history of smoking in the last five years.
•Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
•History of the following cosmetic treatments in the area(s) to be treated:
•Skin tightening procedure within the past year;
•Injectable filler of any type within the past:
•i. 12 months for Hyaluronic acid fillers (e.g. Restylane)
•ii. 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
•iii. 24 months for Long-lasting Hyaluronic acid (Juvéderm Voluma) and Poly-L-Lactic acid fillers (e.g. Sculptra)
•iv. Ever for permanent fillers (e.g. Silicone, ArteFill)
•c. Neurotoxins within the past three months;
•d. Ablative resurfacing laser treatment within the past six months;
•e. Nonablative, rejuvenative laser or light treatment within the past six months;
•f. Surgical dermabrasion or deep facial peels; or
•g. Facelifts within the past year.
•History of using the following prescription medications:
•Accutane or other systemic retinoids within the past six months;
•Topical Retinoids within the past two weeks;
•Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
•Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.