Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%: Comparison Within Subjects (Half Face Method)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Wrinkle Severity Rating Scale (WSRS) grade variation from baseline
研究概览
简要总结
Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method)
详细描述
Comparative, randomized, mono-centre spontaneous trial, under dermatological control, that foresaw the comparison within subjects of the investigational product versus investigational product with Lidocaine 0.3% (half face method); assignation of right or left face side to the two injective treatments was choose by the Investigator according to a previously defined randomisation list.
Primary end point of the study was to evaluate the filling and bio-revitalizing activity on nasolabial folds of the product Aliaxin® EV Essential Volume, in women aged 40-65 years.
It was also aim of this study to show if the addition of Lidocaine 0.3% to the investigational product (extemporaneous mixture) could have reduced the discomfort/pain sensation perceived by the subject during the injection procedure, without altering the aesthetic performance.
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
- 40 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 40-65 years;
- •asking for nasolabial folds correction;
- •execution of any medical/aesthetic procedure, including dental surgery, in the past that foresaw the use of lidocaine as local anesthetic
- •available and able to return to the study site for the post-procedural follow-up examinations;
- •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, without appropriate sun protection;
- •accepting to sign the informed consent form
排除标准
- •Pregnancy;
- •lactation;
- •alcohol or drug abusers;
- •subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- •subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the aesthetic procedure);
- •Body Mass Index (BMI) variation (± 1) during the study period;
- •performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 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 currently or during the previous 3 months.
- •dermatitis;
- •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, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
- •diabetes;
- •endocrine disease;
- •hepatic disorder;
- •renal disorder;
- •cardiac disorder;
- •pulmonary disease;
- •neurological or psychological disease;
- •inflammatory/immunosuppressive disease;
- •drug allergy,
- •anticoagulants and antiplatelet 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),
- •using of drugs able to influence the test results in the investigator opinion.
研究组 & 干预措施
Aliaxin® EV Essential Volume
Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3%
干预措施: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3% (Device)
Aliaxin® EV Essential Volume
Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3%
干预措施: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) (Device)
结局指标
主要结局
Wrinkle Severity Rating Scale (WSRS) grade variation from baseline
时间窗: Baseline visit (T0), Week 4 (T4)
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.
次要结局
- Determination of profilometric parameters(Baseline visit (T0), Week 4 (T4))
- The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline(Baseline visit (T0), Week 4 (T4))
- Self grading(Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h))