A Novel Substrate and Injection Technique for Chin Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Frequency of participants graded as at least 'improved' on the Global Aesthetic Improvement Scale (GAIS) by a blinded evaluator at baseline to Month 12
研究概览
简要总结
The use of hyaluronic acid (HA) fillers for soft tissue augmentation offers a valuable treatment modality for the correction of chin retrusion (i.e., when the chin appears to be set back or further back than normal in relation to the rest of the face). Their use is well-tolerated and provides satisfactory aesthetic results by improving facial balance and projection. Although the efficacy of hyaluronic acid HA fillers for chin augmentation has been established, the specific anatomy of the region may lead to adverse events. More specifically, certain fillers with strong integration characteristics may lead to product migration, while others with poor integration characteristics may lead to palpable deformities and distortion of the surrounding injection tissues.
Using a filler that has a high concentration of hyaluronic acid, a medium level of firmness and low water absorption may offer an effective option for treating this indication while minimizing certain adverse events. In addition, using consistent, standardized injection techniques can help achieve an ideal result.
We believe that the use of a novel HA gel (Revanesse Sculp+) for the chin, with a high concentration of HA, a moderate firmness and low water absorption, will perform better than historical controls with firmer properties in the management of chin retrusion.
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 —（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 participants 18 years of age and older;
- •Participants with established chin retrusion at Baseline (a score of minimal, moderate or severe; based on the Treating Investigator's Allergan Chin Retrusion Scale(ACRS)1 assessment;
- •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;
- •Willing to undergo scheduled CT scans as part of the study design;
- •Females of childbearing potential agree to take a scheduled urinary pregnancy test (UPT) prior to treatment administration.
排除标准
- •Participants without chin retrusion at Screening, per the ACRS1 ;
- •Participants with extreme chin retrusion at Screening as per the ACRS1;
- •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 Revanesse products, hyaluronic acid filler or amide local anesthetics;
- •Participants 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) including but not limited to dental implants;
- •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, piercing, or tattoos in the treatment areas;
- •Facial cancer or precancer (e.g., actinic keratosis);
- •History of radiation therapy to 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;
- •Participants with immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or participants using immunosuppressants;
- •Participants with a tendency to form hypertrophic or keloid scars, or any other healing disorders;
- •Participants with a tendency to form post-inflammatory hyperpigmentation;
- •Participants with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmic);
- •Participants administered dental block or topical administration of lidocaine within 2 weeks of treatment;
- •Participants 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 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;
- •CT scan reveals any bone-related abnormality (e.g., Osteoporosis, Paget's disease, bone infection or cancer), deformity, growths or anything in the Primary Investigator's opinion would interfere with the assessment of any endpoint;
- •Participant is undergoing orthodontic procedures/treatments that manipulate the teeth and underlying bone structure including but not limited to braces and Invisalign treatments;
- •Participants who cannot/should not, for any reason (medical or otherwise), undergo scheduled CT scans (i.e., due to increased safety risks);
- •History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participants participation in this study or would make the participant an unsuitable candidate to receive study medical device;
- •Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- •History of facial nerve palsy
- •Infection or dermatological condition at the treatment injection sites
- •Marked facial dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin
- •Participant has an anticipated need for overnight hospitalization or scheduled surgery;
- •Participant has been treated with any other investigational product at least 30 days before the first administration of the current investigational product.
研究组 & 干预措施
Revanesse Sculpt+
Twenty-one (n = 21) male and female participants aged 18 years or older, including seven (n = 7) participants within each of the Allergan Chin Retrusion Scale(ACRS) categories corresponding to mild, moderate, and severe, based on the assessment of the Treating Investigator, will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion at the Baseline visit (Visit 2) 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: Revanesse Sculpt+ (Device)
结局指标
主要结局
Frequency of participants graded as at least 'improved' on the Global Aesthetic Improvement Scale (GAIS) by a blinded evaluator at baseline to Month 12
时间窗: Baseline to Month 12
Frequency of participants having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), as graded by a blinded evaluator. The Global Aesthetics Improvement Scale (GAIS) is a five-point Likert scale, categorized as "worse", "no change", "improved", "much improved" and "very much improved".
Proportion of participants with ≥1 grade-point improvement from baseline in chin retrusion, as assessed by a blinded evaluator using the CCPS and/or ACRS
时间窗: Baseline to Month 12
The Croma Chin Projection Assessment Scale (CCPS) is a a validated 5-point assessment tool for the projection of the chin using a vertical line from pogonium through the lower vermilion boarder in front of the labiomental crease. It grades chin retrusion from 0 (ideal chin projection) to 4 (very severe retrusion). The Allergan Chin Retrusion Scale (ACRS) is a validated 5-point assessment tool for chin retrusion using the midpoint of the chin and the lower vermillion boarder. It grades chin retrusion from 0 (no retrusion) to 4 (extreme chin retrusion).
次要结局
- Frequency of post-injection reactions including pain and discomfort during treatment, immediately after treatment, and at 14 days post-treatment(Baseline to Month 12)
- Frequency of physician-reported and participant-reported adverse events (AEs) at any visit post-injection(Baseline to Month 12)