NCT02736825终止不适用
Non-Inferiority Study of the Safety and Efficacy of Ultherapy® Using Standard Versus Simulines Transducers at a Reduced Energy Level for Patient Comfort
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ulthera, Inc
- 入组人数
- 262
- 试验地点
- 16
- 主要终点
- Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90
研究概览
简要总结
Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.
详细描述
This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate the efficacy of the Ultherapy treatment with prototype 2 simulines transducers (4-3.0 Smm and 4-4.5 Smm) at energy level (EL) 2 is non-inferior to treatment with standard transducers (7-3.0 mm and 4-4.5mm) at EL 2 for lifting the lower face and neck and to demonstrate the safety of treatment with prototype 2 simulines transducers is similar to treatment with standard transducers.
Changes from baseline in quantitative measures of neck and submental lift will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, Merz Jawline Grading Scale scores, 3D volumetric changes from baseline to post treatment, patient satisfaction and patient-reported improvement will be obtained.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 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 70 years.
- •Subject in good health.
- •Body Mass Index (BMI) of ≤
- •Skin laxity in the area(s) to be treated as determined by trained physician assessors.
- •Willingness to avoid excessive or prolonged exposure to sunlight, tanning booths, sun lamps, or ultraviolet (UV) light sources.
- •Willingness to apply study provided sunscreen (Neocutis Micro-Day Rejuvenating Cream) daily until study exit to help limit sun exposure.
- •Willingness to avoid or periodically stop use of Sunless Tanners (washout period of two weeks prior to each study visit is required).
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
- •Willingness to avoid non-emergent dental procedures in the 3 weeks prior to/ post treatment.
- •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 (e.g. barrier methods used with a spermicidal agent, hormonal methods, intrauterine device (IUD), surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- •a. Postmenopausal for at least 12 months prior to study; b. Without a uterus and/or both ovaries; or c. Bilateral tubal ligation at least six months prior to study enrollment.
- •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. Washout period, if chronic user, for 4 weeks prior to the study treatment. After study treatment is completed, limited acute NSAID use, i.e., a maximum of 2-3 doses in any 2 week period, is allowed if needed.
- •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.
- •History of Bell's Palsy.
- •History of chronic or frequently recurring episodic (recurrent episode in past 12 months) autoimmune diseases such as Multiple Sclerosis, Crohn's Disease, Psoriasis, Myasthenia Gravis, Lambert-Eaton Syndrome that has required immune suppressant therapy (such as biologic drug or corticosteroid treatment).
- •Palpable thyroid lesion, lymphadenopathy, or other pathological changes within the treatment area.
- •History of skin cancer in the areas to be treated, basal cell nevus syndrome, or jaw cysts.
- •Known allergy or sensitivity to Ibuprofen.
- •Severe solar elastosis.
- •Significant changes in weight (e.g. more than 5 pounds) over the past 6 months or anticipated significant changes in weight or diet over the course of the study.
- •Pregnant within the past year.
- •Excessive subcutaneous fat in the area(s) to be treated.
- •Excessive skin laxity in the area(s) to be treated as determined by trained physician assessors.
- •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 two 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.
- •Concurrent 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.
- •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:
- •Any energy based device (radio-frequency (RF), micro-focused ultrasound (MFU), etc.) procedure for skin tightening 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 Hydroxylapatite fillers (e.g. Radiesse)
- •iii. 24 months for Long Lasting Hyaluronic acid (e.g. Voluma) and Poly-L-Lactic acid fillers (e.g. Sculptra)
- •iv. Ever for permanent fillers (e.g. Silicone, ArteFill)
- •c. Neurotoxins within the past six months (neuromodulators are allowed in the glabella and forehead, not allowed in the temples, crow's fee or anywhere below the lateral canthus);
- •d. Fractional and fully ablative resurfacing laser treatment within the past two years;
- •e. Nonablative, rejuvenative laser or light treatment within the past six months;
- •f. Surgical dermabrasion or deep facial peels within the past two years;
- •g. Facelifts, neck surgery (e.g. thyroid, neck lifts, neck liposuction, etc.) within the past two years;
- •h. Micro needling within the past year;
- •i. Kybella, Coolsculpting, or Mesotherapy within the past two years; or
- •j. Any history of contour threads.
- •History (in the prior year) or current use of the following prescription medications:
- •Accutane or other systemic retinoids within the past six months;
- •Initiation of topical retinoids within the past 6 months or throughout the course of the study;
- •Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
- •Systemic steroids including prednisone;
- •Dermal regulators of collagen;
- •Initiation of bioidentical hormones or human growth hormone (HGH) within the past 6 months or throughout the course of the study; or
- •Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
结局指标
主要结局
Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90
时间窗: Day 90
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
次要结局
- Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 180(Day 180)
- Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 365(Day 365)
- Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90(Day 90)
- Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 365(Day 365)
- Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180(Day 180)
- Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 365(Day 365)
- Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 90(Day 90)
- Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 180(Day 180)
- Percent Change From Baseline in Volume as Assessed by Quantificare 3 D Imaging System at Day 90(Day 90)
- Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 180(Day 180)
- Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 365(Day 365)
- Number of Participants With Some Level of Improvement and Satisfaction on Day 90(Day 90)
- Mean Treatment Times(Baseline)
- Mean Pain Scores to Assess Participant's Treatment Related Comfort Level Based on Numeric Rating Scale (NRS)(Baseline)
- Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90(Day 90)
- Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180(Day 180)
- Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 365(Day 365)
研究者
研究点 (16)
Loading locations...
相似试验
已完成
2 期
Study to Investigate Skin Conditions and Patient Assessment of LAS 41002 in the Treatment of Atopic EczemaAtopic EczemaNCT01119313Almirall, S.A.20
已完成
不适用
Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or ScarsFacial LipoatrophyMorphological Asymmetry of the FaceDebilitating ScarsNCT03050723Croma-Pharma GmbH53
已完成
不适用
Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or ScarsFacial LipoatrophyMorphological Asymmetry of the FaceDebilitating ScarsNCT03050749Croma-Pharma GmbH56
进行中（未招募）
不适用
Randomised trial of different stitching techniques for skin surgery.Scarring after standard elliptical skin excision.Surgery - Surgical techniquesACTRN12611000483954icholas Bostock-Ling186
已完成
不适用
Study to Evaluate Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic InjectionsFacial PhotodamageNCT03559972Allergan40