A Single Center Study Evaluating The Clinical Performance and Safety of Hyaluronic Acid-Based Implantable Dermal Fillers Applied to the Face
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- GAIS
研究概览
简要总结
The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data.
详细描述
This study is a single-center, open label clinical follow-up study. The records of volunteers who were treated with Semical brand dermal fillers on the face at the research center and whose photographs are keps in the researcher's records will be evaluated retrospectively by the principle investigator and an independent evaluator.
Volunteers who were used in accordance with the current intended use declared by the manufacturer of Semical Fine, Plus, Ultra Dermal Fillers and Mesolifter as applied in routine practice by the researcher may be included.
The dermal filler application must have been applied to the necessary and determined facial areas, expectations, product safety requirements, and skin structure, with the technique deemed appropriate by the researcher. In order to obtain optimal aesthetic results, an optional touch-up application may have been made 4 weeks after the first application.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Aged greater than or equal to 18 years
- •Female or male
- •Volunteers in good general health
- •Volunteers with soft tissue deficits on mid-face that can be corrected with volume restoration
- •Volunteers who evaluated by investigator as suitable for hyaluronic acid filler applications on her/his lips, nasolabial folds, temporal, perioral, periocular areas
- •Individuas who have not filler, botulinum toxin, laser, chemical peeling or surgery in the 6 months before the Semical dermal filler application
- •No permanent or non-permanent asthetic applications (chemical peeling, dermabrasion, ablative laser application) non-invasive face-lift, botulinum toxin injections, mesotherapy or fat injections after or simultaneously with filler application
- •Volunteers who have not had non-resorbable filler applied before
- •Volunteers who have complete records regarding the criteria to be evaluated in the study
- •Volunteers who do not have heavy and misleading make-up in their before and after photos
- •Volunteers who have not made significant lifestyle changes (diet, physical activity, permanent make-up application)
- •No exposure to extreme temperatures such as sunlight, UV solarium, laser, extreme cold, sauna, Turkish baths
- •All Fitzpatrick skin types
排除标准
- •Patients under 18 years of age
- •Presence of impairment of wound healing or blood flow
- •Known history of allergy to the study product (hyaluronic acid), local anesthetic used (lidocaine) or gran-positive streptococcal proteins
- •Presence or history of keloid formation tendency, hypertrophic scar, shromatosis or discoloration
- •Skin disease with pronounced skin pigmentation
- •Connective tissue disorders
- •Coagulation disorders
- •Existing inflammation / infection at the injection site
- •Frequently recurring facial / labial herpes
- •Permanent or semi-permanent tendon, bone and muscle implants near the area to be application
- •History of allergy in the mouth area
- •Active autoimmune disease or immunosuppressed individuals with immune system problems
- •Diabetes mellitus or uncontrolled systemic disease (endocrine, hepatic, renal, cardiac pulmonary or neurological disorders)
- •Volunteers with acute inflammatory conditions or infections, active herpes infection or history of chronic and recurrent infections
- •Concomitant medications that affect blood circulation (e.g. aspirin, NSAIDs, Vitamin E, topical and systemic corticosteroids, narcotic antidepressants, immunosuppressive drugs; excluding hormonal and contraceptive treatments started before 1 year) and medications and treatments have the potenrial to affect treatment aoutcomes according to the investigator's opinion
- •Known alcohol or drug abuse
- •Subjects who are pregnant or breasfeeding
- •Subjects who have received COVID-19 vaccination within 30 days before dermal filler application
- •Epilepsy or porphyria, congenital or idiopathic methemoglebinemia, or glucose-6-phosphate dehydrogenase deficiency
- •Analgesic dependence or need for continuous use
- •Syphilis or HIV infection
- •Subjects who have undergone medication or surgical treatments that may cause significant changes in body weight after dermal filler application (such as bariatric surgery)
结局指标
主要结局
GAIS
时间窗: From baseline to immediately after injection, 3 months, 6 months, 9 months
Change of Global Aesthetic Improvement Scale evaluated by patient, investigator and independent rater
次要结局
- Adverse events(throughout the entire study)
- WSRS(From baseline to immediately after injection, 3 months, 6 months)
- Satisfaction of volunteer(From baseline to immediately after injection, 3 montsh, 6 months)
- Ease of use(From baseline to immediately after injection, 3 months, 6 months)
- Injection pain(During injection and 15 minutes after injection)