Clinical Assessment of Skin Quality and Efficacy of Dermal Line Improvement Following Four Bipolar Radiofrequency Microneedling Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change of Fine Lines and Wrinkles
研究概览
简要总结
This study intends to evaluate the safety and effectiveness of the InMode Morpheus8 System to treat facial and neck skin and assess its effect on skin quality and dermal lines. This device has been FDA cleared for full body subdermal adipose tissue remodeling.
详细描述
The primary objective of this study is to evaluate the safety and efficacy of a bipolar fractional radiofrequency treatment via use of the InMode Morpheus8 System to achieve skin texture and quality change and to treat facial fine lines and wrinkles of the lower face.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults between ages 21-70 years of age.
- •Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure.
- •Confirmed BMI ≤
- •Subjects who can read, understand, and sign the Informed Consent Form.
- •Subjects willing and able to comply with all study requirements.
- •Fitzpatrick skin type I-VI.
- •Minimum of 1 on the Lemperle Wrinkle Assessment Scale, Allergan Fine Line Scale and Allergan Skin Roughness Scale
- •Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study.
排除标准
- •Active localized or systemic infections, that may alter wound healing.
- •Immunocompromised subjects.
- •Subjects with coagulation disorder.
- •History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
- •Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
- •5 on the Lemperle Wrinkle Assessment Scale or 4 on the Allergan Fine Line Scale and/or Allergan Skin Roughness Scales
- •Scarring in areas to be treated.
- •Tattoos in the treatment areas to be treated.
- •Significant open facial wounds or lesions.
- •Severe or cystic acne in treatment areas.
- •Current active smoker.
- •Use of Accutane (Isotretinoin) within the past 6 months.
- •Use of topical retinoids within 48 hours.
- •Use of prescription anticoagulants.
- •Pacemaker or internal defibrillator.
- •History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin).
- •Subjects on current oral corticosteroid therapy or within the past 6 months
- •Metal implants in the treatment area.
- •In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
- •Subjects with a history of radiation therapy to the treatment area.
- •Subject has a history of allergy to lidocaine or ester-based local anesthetics.
- •Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine.
- •Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation).
- •Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator.
- •Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year.
- •Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area.
- •Subjects have undergone laser and light treatments in the treatment area over the past 3 months.
- •Subjects have undergone superficial peel or microdermabrasion within 4 weeks.
结局指标
主要结局
Change of Fine Lines and Wrinkles
时间窗: Baseline, 3 Months and 6 Months
Lemperle Wrinkle Assessment Scale- wrinkling will be assessed according to scales definitions. 0- No wrinkles 1. Just perceptible wrinkles 2. Shallow wrinkles 3. Moderately thick wrinkles 4. Deep wrinkles, well defined edges 5. Very deep wrinkles, redundant folds Lower value would indicate improvement.
Change of Fine Lines
时间窗: Baseline, 3 Months and 6 Months
Allergan Scale for Fine Lines- fine lines of the midface/cheeks will be assessed according to the scales definition. 0- None 1. Minimal (1-2 superficial lines) 2. Moderate (3-5 superficial lines) 3. Severe (\<5 superficial lines; no crosshatching) 4. Diffuse (diffuse superficial lines; crosshatching) Lower value would indicate improvement
Change of Skin Roughness
时间窗: Baseline, 3 Months and 6 Months
Allergan Skin Roughness Scale Assessment- roughness will be assessed according to the scaled definitions based on skin coarseness, crosshatching and elastosis in midface area. 0- None (smooth visual skin texture) 1. Minimal (slightly course and uneven visual skin texture) 2. Moderate (Moderately coarse and uneven visual skin texture; early elastosis) 3. Severe (severe coarse visual skin texture, crosshatching lines; some elastosis) 4. Diffuse (extreme coarse visual skin texture, deep crosshatched creases; extreme elastosis) Lower value would indicate improvement
Global Aesthetic Improvement Scale (GAIS)
时间窗: 3 Months and 6 Months
Scale will be used to assess aesthetic change 1. Very much improved 2. Much improved 3. Improved 4. No Change 5. Worse Lower value would indicate improvement
次要结局
- Biomechanical Tissue Measurements (Stiffness)(Baseline, 3 Months and 6 Months)
- Adverse Events(Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6)
- Change in Exploratory Thickness/Density- High Resolution Ultrasound(Baseline, 3 Months and 6 Months)
- Biomechanical Tissue Measurements (Energy Absorption)(Baseline, 3 Months and 6 Months)
- Change in Histology Assessments(Baseline and 6 Months)
- Change in Barrier Skin Function- TEWL(Baseline, 3 Months and 6 Months)
- Biomechanical Tissue Measurements (Laxity, Elasticity)(Baseline, 3 Months and 6 Months)
- Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)(Baseline, 3 Months and 6 Months)
- Change in Gene Expression(Baseline and 6 Months)
研究者
Jeffrey M. Kenkel
Principle Investigator
University of Texas Southwestern Medical Center