A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Intense Strong
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 11
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.
详细描述
This will be a post-market, open label, prospective, interventional, confirmatory, evaluator-blinded,multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.
Subjects desiring correction of their jawline profile at the participating sites will be asked to participate in the clinical investigation. According to national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time.
If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 9 months with follow-up and assessments by visits (Visit 2, Visit 3 and Visit 5) and phone call (Visit 4).
Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic (Visit 3 and Visit 5), for evaluation according to GAIS and the exploratory instrumental evaluation of jawline contour. GAIS will be used for blinded-evaluator assessment, treating Investigator assessment and patient satisfaction.
Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2 - optional touch up) will be used to measure pain.
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
- •Adults ≥18 years, males and females.
- •Able and willing to give written informed consent for participation in the investigation.
- •Treating investigator considers the subject's jaw (including or not including chin) amenable to an improvement of at least 1 grade on GAIS. At least one side with either potential to enhance contouring or moderate to severe loss of jawline definition. The grades do not have to be the same on both sides.
- •Ability to follow study instructions and likely to complete all required visits.
排除标准
- •Pregnant or lactating females.
- •Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anesthetic products.
- •Performed or planned surgery below the nose, permanent implant, injection with fat, and deoxycholic acid that may confound the evaluation of safety and performance of the IMD.
- •Any other intradermal injection, such as semi-permanent fillers or botulinum toxins (no complications are allowed), received in the same injection area within 9 months of the Treatment visit (Visit 1) that may confound the evaluation of safety and performance of the IMD.
- •Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
- •Has any chronic or acute skin disease or inflammation (such as pimples, rashes or hives) within or close to the treatment area.
- •Has any treatments (thrombolytics, anticoagulants etc) or disease related to the coagulation system.
- •Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
- •Patients receiving interferon and ribavirin treatment.
- •Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo.
- •Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
- •Employees of the study site or the sponsor directly involved with the conduct of the investigation.
结局指标
主要结局
Primary efficacy endpoint
时间窗: From pre-intervention baseline, at Visit 3 (3 months post baseline).
The primary efficacy endpoint is the blinded-evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, ranges from 1 (exceptional improvement) to 4 (no change) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the jawline according to the GAIS grading. Each side (left and right) will be assessed independently.
Primary safety endpoint
时间窗: From baseline to end of study (9 months)
The primary safety endpoint is to assess the safety of Decoria® Intense Strong, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration.
次要结局
- Secondary endpoint(30 days, 90 days and 270 days post-treatment)
- Secondary endpoint(From baseline to visit 2 (1 month optional touch-up))
- Secondary endpoint(90 days respectively 270 days after IMD injection)
- Secondary endpoint(30 days between visit 1 and visit 2)