Efficacy and Tolerance of an Injectable Medical Device Containing Hyaluronic Acid and Amino Acids: a Monocentric Six-month Open-label Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 25
- 主要终点
- Variation of Wrinkle Severity Rating Scale (WSRS) grade
研究概览
简要总结
Efficacy and tolerance evaluation of an intradermal injective treatment
详细描述
Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of SUNEKOS ® 200 injectable treatment on main sign of face skin photoaging; the micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- female sex;
- •age 45-65 years;
- •mild/moderate cutaneous photoaging according to a reference photographic scale (see Appendix 8)
- •skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III (see par. 8.1)
- •agreeing to present at each study visit without make-up;
- •accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
- •accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study;
- •accepting to sign the Informed consent form.
排除标准
- •Dependent on the volunteers' characteristics
- •Pregnancy;
- •lactation;
- •subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- •Body Mass Index (BMI) variation (± 1) during the study period;
- •subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (T4i) and 2 months (T2M) after the first biomineralizing treatment execution;
- •performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 months prior to the study start;
- •performing permanent filler in the past;
- •change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test;
- •sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
- •subjects whose insufficient adhesion to the study protocol is foreseeable;
- •participation in a similar study actually or during the previous 6 months.
- •Presence of cutaneous disease on the tested area, as lesions, scars, malformations;
- •recurrent facial/labial herpes;
- •clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
- •endocrine disease
- •hepatic disorder
- •renal disorder
- •cardiac disorder
- •pulmonary disease
- •neurological or psychological disease
- •inflammatory/immunosuppressive disease
- •drug allergy.
- •Anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
- •assumption of drugs able to influence the test results in the investigator opinion.
结局指标
主要结局
Variation of Wrinkle Severity Rating Scale (WSRS) grade
时间窗: Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where: Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature. Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched. Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; \<2mm visible fold when stretched. Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.
Variation of Facial Volume Loss Scale (FVLS) grade
时间窗: Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where Grade 1 Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature. Grade 2 An intermediate point between grade 1 and grade 3. Grade 3 Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature. Grade 4 An intermediate point between grade 3 and grade 5. Grade 5 Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature.
次要结局
- Skin plastoelasticity variation(Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M))
- Photographic documentation (3D pictures )(Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M))
- Superficial skin hydration variation(Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M))
- Face volume variation(Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M))
- Variation of profilometric parameters(Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M))
- Deep skin hydration variation(Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M))