NCT03078647已完成不适用
Clinical Study to Evaluate the Safety and Efficacy Performance of the Profound System Using the Dermal and Sub-dermal (SubQ) Cartridges for the Treatment of Cellulite
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations
研究概览
简要总结
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
详细描述
Up to 60 healthy female volunteers, seeking cellulite treatment, 18 to 60 years of age from up to 3 investigational sites.
Prospective, open-label, baseline-controlled, two arms, randomized, clinical study to evaluate the Profound device using the Dermal and SubQ Cartridges for minimally-invasive treatment of the upper thighs and buttocks cellulite appearance.
The treatment areas of the study subjects will be divided into two arms:
- Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a single Profound treatment utilizing the Dermal and SubQ Cartridges
- Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single Profound treatment utilizing the SubQ Cartridge only.
Methodology described in protocol to evaluate efficacy of treatments will be carried out at each 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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent to participate in the study.
- •Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
- •Fitzpatrick Skin Type I to VI.
- •Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
- •Subject cellulite stage II or III as graded using Nurnberger-Muller scale classification (Appendix III).
- •Not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
- •Negative urine pregnancy test as tested prior to each treatment and at the last visit for women of child bearing potential (e.g. not menopause).
- •General good health confirmed by medical history and skin examination of the treated area.
- •Willing to receive the proposed Profound treatment.
- •Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
- •Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
排除标准
- •Subject cellulite stage 0 or I as graded using Nurnberger-Muller scale classification (Appendix III).
- •Subject had surgery or any other procedure for cellulite in the last 6 months.
- •Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- •Known allergy to lidocaine or epinephrine or antibiotics.
- •Active malignancy or history of malignancy in the past 5 years.
- •Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- •Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process).
- •Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- •Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
- •History of significant lymphatic drainage problems.
- •History of cancer which required lymph node biopsy or dissection.
- •Suffering from significant skin conditions in treatment areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- •History of keloid scarring, abnormal wound healing and / or prone to bruising.
- •History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- •Use of isotretinoin (Accutane) within 6 months of treatment or during the study.
- •Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
- •Dysplastic nevi in the area to be treated.
- •Participation in a study of another device or drug within 3 month prior to enrollment or during this study.
- •Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used.
- •Subjects with history of severe edema.
- •As per the Investigator's discretion, any physical or mental condition that might make it unsafe for subject to participate in this study.
研究组 & 干预措施
Profound treatment to small areas
Experimental
Single Profound treatment with the Dermal and/or SubQ cartridges to bra bulge, above the knees or upper arms
干预措施: Profound (Device)
结局指标
主要结局
Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations
时间窗: 1,3 and 6 months post-treatment
Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement. The analysis calculates the improvement over 25% (grades 2-4)
次要结局
- Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations(1, 3 and 6 months post treatment visit.)
- Investigator Satisfaction - by Questionnaire(1, 3, and 6 months post-treatment visit)
- Subject Satisfaction and Improvement - by Questionnaire(1, 3, and 6 months post-treatment visit)
研究者
研究点 (3)
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