Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Jalucomplex® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial and Neck Dermal Tissue Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Investigator Global Assessment of Performance (IGAP)
研究概览
简要总结
The Research Question of the present study is the following: in a population of men and women presenting facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects) will linear hyaluronic acid (Jalucomplex®) significantly decrease and / or improve their appearance, results observed after 4 and 8 weeks?
详细描述
Jalucomplex® action is to increase the volume of dermal-epidermal tissue, based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times greater than their weight. This allows to fill the intradermal spaces and integrate the intercellular matrix, conferring turgidity to the tissues. Linear hyaluronic acid is a polymer that represents one of the essential components of human skin, subcutaneous and connective tissue; its ability to form complexes with water molecules increases the level of tissue hydration, turgidity and plasticity. These characteristics allow Jalucomplex® to be used as a temporary filler for subcutaneous areas to correct small defects in the dermal tissue due to lipodystrophies or the presence of fibrotic tissues as scars, caused by pathologies or trauma. Non-crosslinked hyaluronic acid generates a lower reactivity that crosslinked forms, biocompatibility of hyaluronic acid-based materials decreasing with an increase in the number of modifications to this polysaccharide
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women with age ≥ 18 and ≤ 65 years.
- •Patients with facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects), caused both by pathologies or trauma, seeking tissue augmentation treatment and willing to receive HA Filler.
- •Patients who agree to discontinue any other dermatological treatment and procedures during the study.
- •Patients willing to provide signed informed consent to clinical investigation participation.
- •Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
排除标准
- •Past or current bleeding disorders.
- •Use of aspirin and antiplatelet agents a week prior to treatment.
- •Prior or planned use of topical injection to the face and the neck (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.).
- •Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
- •History of anaphylaxis or severe complicated allergy symptoms.
- •Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.
- •Known hypersensitivity skin reaction to hyaluronic acid or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit
- •Evidence or history of autoimmune disease or compromised immune system.
- •Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation.
- •Prior permanent fillers or fat graft procedures around facial and neck dermal tissue defects.
- •Facial and neck dermal tissue defects correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photo-rejuvenation, etc.) around infraorbital region within 6 months prior to study participation.
- •History of hypersensitivity to local anaesthetic of amide type or HA.
- •History of keloid formation on the face and the neck.
- •Evidence of active infection on the face and the neck.
- •Wound, skin disorder or infection around facial and neck dermal tissue that may affect the efficacy assessment.
- •Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception* during the study. *Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
- •Need to exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment.
- •Need to have direct or indirect contact with quaternary ammonium salts during the study.
- •As with all dermal filler procedures, the product should not be used in vascular rich areas. Using the product at sites such as Glabella and nose may inadvertently be injected into the blood vessels, resulting in symptom of vessel occlusion such as colour vision deficiency and blindness.
- •Patients with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study.
- •Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
结局指标
主要结局
Investigator Global Assessment of Performance (IGAP)
时间窗: 8 weeks
To evaluate the global performance of product assessed by Investigator through photos taken at each visit (IGAP), at week 8 (day 56), compared to Visit 1 (day 0)
Adverse device event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough adverse device event incidence assessed by Investigators at all visits and reported according to the current legislation
Adverse event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Adverse event incidence assessed by Investigators at all visits and reported according to the current legislation
POSAS score assessed by Investigator and patient
时间窗: 4 weeks
To evaluate the overall performance of the medical dermal filler Jalucomplex® in treating facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score, assessed by Investigators and patients at 4 (28 days) after the initiation of treatment, compared to Visit 1 (day 0).
Serious adverse event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
Serious adverse device event incidence
时间窗: 8 weeks
To evaluate the safety of the device trough Serious adverse device event incidence assessed by Investigators at all visits and reported according to the current legislation
次要结局
- Treatment satisfaction assessment by the patient(8 weeks)
- Patient Global Assessment of Safety (PGAS).(8 weeks)
- Global Aesthetic Improvement Scale evaluated by the patient (GAIS)(8 weeks)
- Investigator Global Assessment of Safety (IGAS)(8 weeks)