NCT01981252终止不适用
Evaluation of the Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions
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
- 90
- 试验地点
- 10
- 主要终点
- Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.
研究概览
简要总结
This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 30 to 75 years.
- •Subject in good health.
- •Fitzpatrick wrinkle score of 3-7 in the peri-orbital and peri-oral areas.
- •Moderate skin laxity in the peri-orbital area contributing to rhytids as assessed by the investigator.
- •Understands and accepts the obligation not to undergo any other procedures, including neurotoxin and filler treatments, on the face through the follow-up period.
- •Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment.
- •Willingness and ability to continue with their current daily skin care routine, with the exception of any use of products containing glycolic acid, for the duration of the study.
- •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 and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- •Willingness and ability to provide written informed consent and 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.
- •BMI equal to or greater than 25
- •Severe solar elastosis.
- •Excessive subcutaneous fat in the area(s) to be treated.
- •Mild or severe skin laxity on the area(s) to be treated.
- •Significant scarring in the area(s) to be treated.
- •Open wounds or lesions in the area(s) to be treated.
- •Severe or cystic acne on the area(s) to be treated.
- •Active implantables (e.g., pacemakers or defibrillators) or metallic implants in the treatment area.
- •Inability to understand the protocol or to give informed consent.
- •Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 weeks prior to study participation or during the study.
- •Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
- •History of chronic drug or alcohol abuse.
- •History of autoimmune disease.
- •History of Bell's Palsy or epilepsy.
- •History of diabetes.
- •Has a known allergy, or a known history of sensitivity, to lidocaine, tetracaine, para-aminobenzoic acid (PABA).
- •Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- •Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- •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.
- •History of the following cosmetic treatments in the area(s) to be treated:
- •Skin tightening procedure within the past year;
- •Injectable fillers of any type within the past 12 or 24 months, depending on type;
- •Neurotoxins within the past six months;
- •Ablative resurfacing laser treatment;
- •Nonablative, rejuvenative laser or light treatment within the past six months;
- •Surgical dermabrasion or deep facial peels;
- •Facelift, blepharoplasty, or browlift within the past 2 years; or
- •Any history of contour threads.
- •History of using the following prescription medications:
- •Accutane or other systemic retinoids within the past six months;
- •Topical Retinoids within the past four weeks;
- •Antiplatelet agents/Anticoagulants;
- •Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
研究组 & 干预措施
Ulthera® System Treatment
Experimental
Ulthera® System treatment of the peri-orbital and peri-oral regions.
干预措施: Ulthera® System Treatment (Device)
结局指标
主要结局
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.
时间窗: Participants will be followed to 90 days post-treatment #2
Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2.
次要结局
- Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2.(Participants will be followed to 180 days post-treatment #2)
- Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 90 days post treatment #2.(Participants will be followed to 90 days post-treatment #2)
- Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 180 days Post Treatment #2.(Participants will be followed to 180 days post-treatment #2)
- Overall Aesthetic Improvement(Participants will be followed to 180 days post-treatment #2)
- Subject Satisfaction(Participants will be followed to 90 days post-treatment #2)
研究者
研究点 (10)
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