An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler mIntense L+AS, Hyaluronic Acid 25 mg/ml (M-INT-LS) for Soft Tissue Augmentation to Correction of Moderate to Deep Wrinkles and Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Frequency and severity of AEs, SAEs, ISRs, TEAEs
研究概览
简要总结
The investigation is a single-centre, interventional, prospective, non-randomized, open-label, uncontrolled, single-arm, un-blinded investigation for evaluation of the safety and performance of the product mIntense L+AS in the treatment of small skin defects, such as wrinkles or scars. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.
详细描述
The product mIntense L+AS is a dermal filler manufactured by mesoestetic Pharma Group s.l. It was intended to be used as a temporary filler to correct small skin defects, such as wrinkles or scars. In particular, it was recommended for the treatment of deep wrinkles.
mIntense L+AS for the facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable product containing cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation.
This clinical investigation was conducted as an uncontrolled - no comparator was used. The safety and performance of the treatment were evaluated by comparison of the condition with the state of the treated area before initiation of the procedure, conducted by the trained Principal Investigator.
The investigated product mIntense L+AS was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. Both sessions were conducted within 14-day intervals.
The evaluation process during the medical examination was facilitated by photographic evidence taken before and after therapy at predetermined time points for reference.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged ≥18 and ≤70 years;
- •Subjects showing signs of facial skin depressions, scars or deep wrinkles;
- •Aesthetic scores of 3 or 4 (moderate or substantial loss of midface fullness, respectively) on each side of the face assessed at baseline by the investigator;
- •Subject who is willing to abstain from any other facial aesthetic or cosmetic procedure or plastic surgery during the clinical investigation, including follow-up period;
- •Subject who understands and is willing to comply with all investigation-related activities and who is available for the duration of their participation in the investigation, including follow-up;
- •Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid, lidocaine or other anesthetics or nerve-blocking agents;
- •Arterial blood pressure (BP) (after 5 min. at rest in the supine position) in reference range - systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;
- •Heart rate (HR) (after 5 min. at rest in the supine position) in reference range - over 50 beats/min and less than 100 beats/min;
- •Body temperature of up to 37°С;
- •Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities for CBC, ESR, PT/INR;
- •Negative pregnancy test for the women with reproductive potential;
- •Reliable and acceptable method of contraception for the women of child-bearing potential:
- •IUD, inserted at least 3 months prior to the investigation initiation;
- •Double barrier method (condom, spermicide-containing diaphragm) applied at least 14 days prior to the first investigated product application and throughout the course of the investigation;
- •Hormonal contraception with use initiation at least 3 months prior to the first investigated product application and throughout the course of the investigation;
- •Sexual abstinence for at least 14 days prior to enrollment into the investigation and throughout the course of the investigation;
- •Surgical sterilisation (bilateral ligation of the uterine tubes, hysterectomy, bilateral ovariectomy or vasectomy of the regular partner) with no less than a 6-month history;
- •Menopause with no less than a 2-year history prior to the investigation initiation.
- •Signed written Informed Consent Form by the adult participant.
排除标准
- •Subject with known serious multiple allergies, sensitivity to any of the active ingredients (hyaluronic acid, lidocaine) or other anesthetics or nerve-blocking agents, or significant allergy or hypersensitivity to food and drugs;
- •History of any disease resulting in changes of facial contour or oedema of the face during the clinical investigation period;
- •Ascertained tendency to develop hypertrophic or keloid scars or pigmentation disorders;
- •History of connective tissues diseases;
- •History of active autoimmune diseases or those under immunotherapy;
- •History of or laboratory results suggesting coagulation disorder;
- •Active skin disease or inflammation of or near the injection area that could interfere with the clinical investigation injections or assessments;
- •Subject who suffers from another medical condition or who is receiving medication that in the Principal Investigator's judgment would prohibit inclusion in this investigation;
- •Soft tissue augmentation with bovine collagen (in the previous 6 months), with porcine or human collagen (in the previous 12 months), or with hyaluronic acid or hydroxyapatite (in the previous 18 months);
- •Subject with permanent implants in the neck or face within the previous 36 months;
- •Any aesthetic treatment/procedure of the face in the previous 6 months that may interfere with the investigations injections and/or investigation assessments, as judged by the investigator;
- •Presence of any condition, which in the opinion of the investigator, makes the subject unable to complete the clinical investigation as per this CIP;
- •Subject who is currently participating in another clinical investigation which may interfere with this clinical investigation results or who had participated in another clinical investigation within 30 days prior to enrollment in this investigation;
- •Pregnancy, postpartum period (6 months), lactation or post-lactation period (6 months);
- •Absence of a reliable and effective method of contraception for subject with childbearing potential;
- •Known abuse of drugs, alcohol or other substances;
- •Subject with limited mental and consistent comprehension abilities; incapacitated subjects; sportsmen and individuals on strenuous physical loading; prisoners;
- •Refusal to sign the Informed Consent Form by the adult participant.
结局指标
主要结局
Frequency and severity of AEs, SAEs, ISRs, TEAEs
时间窗: Two months after the first treatment (Session 3 (Day 60))
The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature
次要结局
- Visual Analogous Scale (VAS) - principal investigator evaluation(Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365))
- Wrinkle Severity Rating Scale (WSRS) - patient evaluation(Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365))
- Global Aesthetic Improvement Scale (GAIS) - patient evaluation(Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365))
- Wrinkle Severity Rating Scale (WSRS) - principal investigator evaluation(Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365))
- Global Aesthetic Improvement Scale (GAIS) - principal investigator evaluation(Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365))
- Subject satisfaction(Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365))
- Visual Analogous Scale (VAS) - patient evaluation(Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365))
- Frequency and severity of AEs, SAEs, ISRs, TEAEs(Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365))