PROSPECTIVE, INTERVENTIONAL, NON-RANDOMIZED, OPEN LABEL, BLINDED STUDY FOR THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hallura Ltd.
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Responder Rate
研究概览
简要总结
Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subject;
- •Male or female, over the age of 18;
- •Female patients of childbearing potential must declare in the ICF to be non-pregnant at visit 1a prior to initial injection and should use a contraceptive regimen recognized as effective since at least 12 weeks before the beginning of the study, and during the entire duration of the study.
- •Subject seeking an aesthetic procedure on the face who can be classified into one of the following groups:
- •Group1: Lip volume deficit with ROSSI score between 1.5 and 3 on at least the upper lip, or on both the upper and the lower lips with up to 1-point difference in ROSSI score between upper and lower lips;
- •Group 2: Moderate to severe nasolabial folds (NLFs) with WSRS scale score 3 or 4 for each side of the face;
- •Group 3: Mild to significant volume deficit at the cheeks level with MFVDS score 3 to 4 at each side, with up to 1-point difference in MFVDS scale score between the two sides.
- •Blinded Live-Evaluator (BLE) and Injector (ILE) must independently agree that the criteria is met on the area to be treated, however concordance of the scores is not required.
- •Subject willing to abstain from any aesthetic treatment on the treated area other than the treatments planned in the protocol during the study period.
- •Subject informed and having signed and dated the EC approved informed consent form (ICF).
- •Subjects agree that his/her imaging will be published without partial covering of the photo, meaning without Anonymization for R&D, business development, Marketing of Hallura and Publications and for evaluating the 3D imaging by cherry imaging for internal R&D use.
排除标准
- •In terms of population
- •Subject with abnormal vision assessment at Baseline: either Snellen acuity test worse than 20/40 (with corrections, if applicable) or abnormal confrontational visual field test or abnormal ocular motility test.
- •Subject who is pregnant or nursing or planning to become pregnant during the study.
- •Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship, such as social or sanitary establishment.
- •Subject suspected to be non-compliant according to the investigator's judgment.
- •Participation in another clinical trial concurrent with this study.
- •In terms of associated pathology and concomitant treatment
- •Subject with a condition or receiving a medication which, in the investigator's judgment, puts the subject under risk.
- •Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- •Subject with mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease, and/or severe malocclusion or dentofacial or maxillofacial deformities.
- •Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- •Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma, rosacea, blotches or other pathology on the studied zones, at the investigator appreciation). Subject with recurrent herpes is not eligible even if asymptomatic at time of inclusion.
- •Subject who has a known history of multiple allergies, allergic/anaphylactic reactions including allergy to lidocaine or anaesthetics of the amide type, to hyaluronic acid products, or to Gram-positive bacterial proteins.
- •Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats.
- •Subject with a history of precancerous lesions/skin malignancies.
- •Subject predisposed to keloids or hypertrophic scarring.
- •Subject with known history of hyper- or hypo-pigmentation in face.
- •Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- •Subject having received high dose of Lidocaine (more than 200mg) and/or high dose of anaesthetics structurally related to amide-type during the week before the injection session.
- •Have received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, garlic, gingko), fish oil or vitamin C from 10 days pre- to 3 days post injection [Study device injections may be delayed as necessary to accommodate this 10-day washout period.]
- •For group 1, abnormal rating in lip movement / lip function / lip sensation.
- •Subject undergoing one of the following systemic or topical (on the test area) treatments:
- •anti-histamines during the 2 weeks prior to study start;
- •immunosuppressors and/or corticoids during the 4 weeks prior to study start;
- •retinoids during the 6 months prior to study start.
- •Subjects suffering from untreated epilepsy;
- •In terms of lifestyle
- •Subject having received injection with a temporary bioresorbable facial dermal filler (e.g., hyaluronic acid, collagen, autologous fat, etc.) within the past 12 months prior to study start.
- •Botulinum toxin injections, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study.
- •Subjects having received at any time permanent facial implants (e.g. polyacrylamide, PMMA, silicone) anywhere in the face or neck.
- •Had undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid, etc.) in the face within 24 months before enrolment.
- •Subject having received at any time a treatment with tensor threads or gold strands on the face.
- •Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
- •Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
研究组 & 干预措施
Group 1 - Lips
HLR-1, maximum of 3ml per upper and lower lip area, (1.5ml max at the touch-up treat
干预措施: HLR-1 (Device)
Group 2 - Nasolabial folds (NLF)
HLR-2, maximum of 3ml per NLF, (1.5ml max at the touch-up treatment, if performed) injected in the mid to deep dermis.
干预措施: HLR-2 (Device)
Group 3 - Cheeks
HLR-3, maximum of 4ml per side, (2 ml max at the touch-up treatment, if performed) injected in the deep dermis or subcutaneous to supraperiosteal layers of the cheeks.
干预措施: HLR-3 (Device)
结局指标
主要结局
Responder Rate
时间窗: 3 months for Group 1, 6 months for Groups 2 and 3
Clinical scoring: The assessment of lip volume, wrinkles severity of nasolabial folds and cheeks volume will be performed by the ILE and validated with BLE (blinded live evaluator) assessment using the respectively structured scale ROSSI, WSRS or MFVDS. At each scoring event, one score for the upper lip will be given for subjects in group 1, two scores for right and left NLF for subjects in group 2 and two scores for right and left cheeks for subjects in group 3. For each group, in order to demonstrate a product efficacy, the responder rate proportion in clinical scoring should be significantly higher than 60% using a one-tailed binomial test at the Alpha=0.05 significance level.
Safety Evaluation
时间窗: 12 months after the injection
Prior to statistical analyses, all the AEs will be coded using the Medical Dictionary MedDRA®. Will be presented by System Organ Class and Preferred Term: * All Adverse Events * All Serious Adverse Events * All Adverse Device Effects The number and percentage of patients experiencing at least one AE / SAE / ADE occurring over 6 months and 12 months after the injection will be provided as well. AEs will also be tabulated by: * Seriousness criterion * Severity * Relationship with the product * Relationship with CIP procedure * Outcome The individual listing of AE will be provided. The main analysis will be performed globally on the entire safety population over the 3 groups. Analysis per group will also be realized, as well as broken down by sub-group of subjects with and without touch-up.
次要结局
未报告次要终点