NCT06336772已完成不适用
A Comparative Trial Evaluating Restylane Shaype Versus Juvederm Volux for Chin Augmentation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Statistically significant group differences in the average three-dimensional volumetric increase since baseline
研究概览
简要总结
This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At the time of consent, male and female subjects 18 years of age and older.
- •Patients with established chin retrusion at Baseline (a score of mild, moderate, and severe severity on the Galderma Chin Retrusion Scale).
- •Accepted the obligation not to receive any other facial procedures throughout the study duration.
- •Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits.
- •No previous lower face fillers for 12 months prior to this study.
- •Capable of providing informed consent.
排除标准
- •Patients without chin retrusion at Baseline, per the Galderma Chin Retrusion Scale.
- •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 Restylane or Juvéderm products, hyaluronic acid filler or amide local anesthetics.
- •Patients presenting with porphyria or any other liver diseases.
- •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 since drug allergies might preclude optimal management of complications.
- •Previous tissue revitalization therapy in the treatment area (i.e., the lower face) within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion.
- •Previous facial surgery, including liposuction.
- •Lifetime history of permanent implants in the treatment region (i.e., the lower face)
- •Lifetime history of semi-permanent dermal fillers in the treatment region (i.e., the lower face).
- •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.
- •Active facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes zoster or any other facial condition that may increase the risk of cutaneous penetration of infective agents.
- •Scars, deformities, piercings, or tattoos in the treatment areas.
- •Facial cancer or precancer (e.g., actinic keratosis).
- •History of radiation therapy in the treatment area.
- •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 with immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or subjects using immunosuppressants.
- •Patients with a tendency to form hypertrophic or keloid scars, or any other healing disorders.
- •Patients with a tendency to form post-inflammatory hyperpigmentation.
- •Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anesthetics (e.g., certain anti-arrhythmics).
- •Patients administered dental block or topical administration of lidocaine within 2 weeks of treatment.
- •Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
- •Current remote infections (e.g., urinary tract, sinuses, intestinal tract, oral cavity)
- •Planned dental procedures during the 2-week period before and after filler treatments, including teeth cleaning, tooth extraction and gum grafts.
- •Planned COVID-19 vaccinations during the 2-week period before and after filler treatments.
- •Lifetime history of cystic acne, due to increased risk of cyst development following filler treatment.
结局指标
主要结局
Statistically significant group differences in the average three-dimensional volumetric increase since baseline
时间窗: Baseline to Week 2, Week 4, Week 12, Week 24
As assessed by the Canfield Vectra XT system.
次要结局
- Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale)(Baseline to Week 2, Week 4, Week 12, Week 24)
- Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues)(Baseline to Week 2, Week 4, Week 12, Week 24)
- Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale)(Baseline to Week 2, Week 4, Week 12, Week 24)
研究者
研究点 (2)
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