An Open, Non-comparative, Single-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety of the ALIAXIN Fillers Used as Intended
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- To evaluate the re-volumizing performance of the filler ALIAXIN during all study duration compared to baseline volume. Change will be assessed.
研究概览
简要总结
This is an open, non-comparative, Single-centre Post Marketing Clinical Followup (PMCF) study aimed to enrol patients with medium and deep facial sagging, facial volume defects and/or lips volume and contours defects. The investigation will be useful to collect Investigational Product' real world safety /performance evidences in normal clinical practice. Each subject, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted. At baseline visit (Visit 0), as per clinical practice, the subject can be treated with one or more of the below ALIAXIN products, depending on investigator clinical evaluation and decision:
- ALIAXIN EV: Essential Volume
- ALIAXIN FL: Lips
- ALIAXIN SR: Shape & Restore
- ALIAXIN GP: Global Performance
- ALIAXIN LV: Lips Volume According the investigator judgment and IP' Instruction For Use (IFU), each subject can be treated in one or more of following face area:
- Temporal / frontal area
- Orbital / Malar area
- Perioral area
- Lips. For the pre- and post-treatment clinical evaluations, a LifeViz® Mini 3D camera (QuantifiCare) will be used for face-images capture. A LifeViz® Micro 3D camera (QuantifiCare) will be used for adjuvant images capture, only in specific conditions (e.g. nasolabial folds and marionette lines) and according to the Principal Investigator judgment, to facilitate the clinical evaluation. As per clinical practice, the treatment can be repeated at touch up visit (Visit 1), after 15 days from Visit 0, according the investigator clinical evaluation and decision, to maintain/refine the obtained results. Moreover, after 6 months from Visit 0, as per clinical practice, a visit ( Visit 2, End of Study Visit) will be performed to collect and evaluate the safety and performance of treatment(s) performed. Considering the normal clinical practice, after Visit 2, according the investigator judgment and after a new Informed Consent Form signature, the subject can be enrolled in a new screening phase as per clinical study design. The re-enrolled subject should meet all inclusion and none exclusion criteria. In the new CRF will be reported the previous subject's identification number.
详细描述
Aesthetic Dermatology (AD) is a rapidly developing part of dermatology in science and clinical practice.
The focus, however, needs to be patient-centered and the work scientific to avoid the ethical dilemma.
The growing patient population and appeal for rapid results have served as an impetus that transformed the use of soft tissue fillers. While clinicians established innovative ways to address multidimensional deficiencies of the face, manufacturers developed new formulations to address the tasks faced by clinicians. With these advancements, it is essential that facial plastic surgeons are adept at cosmetic applications of soft tissue fillers to provide quality care and optimize patient outcomes.
Today, there are a variety of injectable soft tissue fillers available for clinical use with over 160 products belonging to > 50 companies on the market. Factors such as defect type and location, preferred durationof effect, and clinician expertise with specific agents determine the most approp riate choice of agent. These fillers can be categorized into resorbable (biodegradeable), nonresorbable (permanent), and viable autologous fat. Resorbable fillers include hyaluronic acid (HA), collagen, calcium hydroxylapatite, and poly-L-lactic acid with HA-based fillers being the most common injectable agents used today. Common permanent fillers include polymethylmethacrylate (PMMA) microspheres, hydrogel polymers, and silicone injections. Because most patients are satisfied with temporary filler use, the decision to pursue permanent fillers must be considered carefully.
Hyaluronic acid (HA) is a naturally occurring polysaccharide frequently used as a functional ingredient in subcutaneous antiaging treatments, such as dermal fillers, which use the polymer's unique viscoelastic properties. The major challenge lies in the reasoned choice of the product to be used depending on the anatomical area to be corrected. Indeed, each region of the face is subjected to specific mechanical constraints, which the authors take into account when selecting HA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Informed consent form (ICF) signed;
- •M & F Aged ≥ 18 years at the time of the signature of ICF;
- •Patients with medium and deep facial sagging, facial volume defects and/or lips volume and contours defects (nasolabial folds, wrinkles around the mouth facial and acne scars, glabellar wrinkles, wrinkles on the forehead, areas of the face which require enrichment of the facial tissue - cheeks, chin, cheekbones, lips - with temporary volumetric increase through growth of the soft tissues).
- •Willing to follow all study procedures, including attending all site visits, tests and examinations;
- •Willing to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions or laser) or intense cold after the treatment and until the complete absorption of swelling and reddening.
排除标准
- •Other - different - clinical conditions of skin layers;
- •Sagging and volume defects in other parts of the body different from face;
- •Infective or inflammatory processes near the area of intervention;
- •Presence of tendon, bone or muscular implants near the area of intervention;
- •Ongoing cutaneous allergies;
- •Serious and Chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy;
- •Known hypersensitivity to cheloids;
- •Allergy to device components;
- •Immune system illnesses;
- •Diabetes mellitus or uncontrolled systemic diseases;
- •Problems with coagulation or anti-coagulating therapies in progress;
- •Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAID, Vitamin E);
- •History of permanent filler treatment;
- •Known drug and/or alcohol abuse;
- •Mental incapacity that precludes adequate understanding or cooperation;
- •Participation in another investigational study;
- •Pregnancy Status (as per ALIAXIN products leaflet).
结局指标
主要结局
To evaluate the re-volumizing performance of the filler ALIAXIN during all study duration compared to baseline volume. Change will be assessed.
时间窗: V-1(Week -1 Screening visit), V0 (Baseline visit day 0, IP administration). V-1 and V0 may coincide. V1 (15 days from V0) and V2 (6 months from V0). Change will be assessed.
To evaluate the re-volumizing performance of the filler ALIAXIN (Essential Volume (EV), Lips (FL), Shape \& Restore (SR), Global Performance (GP) and Lips Volume (LV)) used as Intended in patients with facial volume defects, by treated areas calculating the volume variation (expressed as cm3) during all study duration compared to baseline volume. A 3D camera will be used to take subject' face images at all planned visits.
次要结局
- To evaluate the corrective performance of the ALIAXIN fillers during all study duration by Global Aesthetic Improvement Scale (GAIS).(V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) and V2 (6 months from V0).)
- To evaluate the tolerability and patient satisfaction of the filler ALIAXIN during all study duration.(V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) and V2 (6 months from V0).)
- To evaluate the re-volumizing performance of each Filler ALIAXIN during all study duration compared to baseline volume. Change will be assessed.(V-1(Week -1 Screening visit), V0 (Baseline visit day 0, IP administration). V-1 and V0 may coincide. V1 (15 days from V0) and V2 (6 months from V0). Change will be assessed.)