A Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria® Essence
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Primary efficacy endpoint to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS)
研究概览
简要总结
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
详细描述
A post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
Subjects desiring correction and improvement of their lip 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 6 months with follow-up and assessments by visits in the clinic (Visit 2, Visit 3 and 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, Visit 4 and Visit 5). The photographs will be used for the evaluation of the primary efficacy endpoint of the blinded-evaluator using the Global Aesthetic Improvement Scale (GAIS) as well as the exploratory instrumental evaluation of the lip 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 lips amenable to an improvement of at least 1 grade on the GAIS. At least one lip should either have a potential to change (augmentation, contouring or both) or have moderate to severe volume deficit. The grades do not have to be the same on both lips.
- •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 anaesthetic 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.
- •Subjects receiving interferon and ribavirin treatment.
- •Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo below the nose.
- •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 to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS)
时间窗: From pre-intervention baseline (Visit 1, Day 0) to month 3 (Visit 3, Day 90).
The primary efficacy endpoint is to measure the change/improvement in score from pre-treatment baseline to 3 months post treatment by an independent evaluator, 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 (unaltered) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the lips according to the GAIS grading. Each lip (upper and lower) will be assessed independently.
Primary safety endpoint by evaluating Adverse Events
时间窗: From inclusion until the end of the study (6 months)
The primary safety endpoint is to assess the safety of Decoria® Essence, evaluated by the incidence, intensity, duration, and time of onset of related adverse events (AEs), including injection site reactions, collected during study duration.
次要结局
- Secondary endpoint evaluating pain by Numeric Pain Rating Scale (NRS)(At baseline (Visit 1, Day 0) and optional touch-up (Visit 2, Day 30))
- Secondary endpoint evaluated improvement by GAIS score(At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180))
- Secondary endpoint by evaluating improvement by GAIS(At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180))
- Secondary endpoint evaluating treatment related Adverse Events(30 days after injection of initial treatment (Day 0-30) and optional touch-up (Day 30-60))
- Secondary endpoint by instrumental evaluation of lips by image analysis.(From pre-intervention baseline, to post-treatment at Day 1, 30, 90 and 180 respectively)
- Secondary endpoint evaluated outcome by GAIS score(At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180))