NCT04172740已完成不适用
Assessment of Skin Quality Parameters Following RADIESSE Injection in Perioral and Marionette Lines
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Hydration
研究概览
简要总结
Following treatment with Radiesse, many patients mention an improvement in skin texture This observation is independent from the improvement observed on their facial shape. There is therefore a need to identify and quantify changes in skin parameters following treatment with Radiesse
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At the time of consent, women between the ages of 18 and 80 years old;
- •Patient requires lower face treatment (perioral/marionette region) with RADIESSE;
- •Willingness to comply with study requirements;
- •Provide written consent;
- •Patient has a rating of 2 or 3 at Baseline on the Merz Marionette Grading Scale, as per the investigator;
- •Accepted the obligation not to receive any other facial procedures through the follow-up;
- •Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
- •No previous facial fillers for a period of 12 months prior to this study;
- •No previous facial fillers in the lower face for 18 months prior to this study.
排除标准
- •Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- •Hypersensitivity to RADIESSE, calcium hydroxylpatite filler or local anesthetics;
- •Patient has received any lower face treatment during the last 12 months, or neuromodulator in the last 6 months;
- •Patient has received mentalis muscle injections of any kind (BoNT-A or fillers) in the last 6 months;
- •Patients meeting any official RADIESSE contra-indications;
- •Patients presenting with porphyria;
- •Inability to comply with follow-up and abstain from facial injections during the study period;
- •Heavy smokers, classified as smoking more than 12 cigarettes per day;
- •History of severe or multiple allergies manifested by anaphylaxis;
- •Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
- •Previous surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
- •History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
- •Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area;
- •Cancer or precancer in the treatment area, e.g. actinic keratosis;
- •History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
- •Patients using immunosuppressants;
- •Patients with a tendency to form hypertrophic scars or any other healing disorders;
- •Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
- •Patients administered dental block or topical administration of lidocaine;
- •Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
结局指标
主要结局
Hydration
时间窗: Month 3
Assessment of changes in hydration at Month 3, as assessed with the Courage and Khazaka system device, following the injection of RADIESSE, in perioral and marionette lines regions
次要结局
- Hydration(Month 6)
- Skin texture(Month 3 and 6)
- Global Assessment Improvement Scale(Months 3 and 6)
- Elasticity(Month 3 and 6)
- pH(Month 3 and 6)
- Merz validated marionette scale(Month 3 and 6)
- Fitzpatrick Wrinkle Assessment Scale(Months 3 and 6)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of ColorNasolabial FoldsNCT01012388Merz North America, Inc.100
已完成
4 期
Injectable Filler for Cheek FlatteningMalar DeficiencyNCT01225354DeNova Research20
已完成
不适用
Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices ViscolAesthetic DermatologyNCT06142643Kylane Laboratoires86
已完成
不适用
Efficacy test of CNT for skin.Healthy femalesJPRN-UMIN000039625Kao Corporation20
已完成
不适用
Evaluation of improvement of skin condition by cream cosmeticsHealthy adult femaleJPRN-UMIN000033232Japan Clinical Trial Association18