NCT06336772已完成不适用
A Comparative Trial Evaluating Restylane Shaype Versus Juvederm Volux for Chin Augmentation
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
- 40
- 试验地点
- 1
- 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.
研究组 & 干预措施
Restylane Shaype
Experimental
Restylane Shaype is approved and commercially available for use in Canada and is manufactured by Q-Med AB, part of the Galderma Group.
The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.
干预措施: Restylane Shaype (Device)
Juvederm Volux
Active Comparator
Juvéderm Volux is approved and commercially available for use in Canada and is manufactured by Allergan Aesthetics, an Abbvie company.
The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.
干预措施: Juvéderm Volux (Device)
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 (1)
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