Aesthetic Performance and Tolerance Evaluation of "Profhilo®" Injective Intradermal Treatment for the Skin Roughness and Laxity of the Neck

Derming SRL2 个研究点分布在 1 个国家目标入组 25 人开始时间: 2019年2月18日最近更新: 2019年7月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Derming SRL
入组人数: 25
试验地点: 2
主要终点: Change from baseline of neck skin roughness and laxity clinical grade

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.

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,
•40-65 years,
•3-4 neck roughness/laxity grade according to a clinical reference scale;
•asking for neck laxity and roughness restoration;
•available and able to return to the study site for the post-procedural follow-up examinations;
•accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the neck;
•accepting to not expose their neck 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 abuse and/or drug use;
•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 1st aesthetic procedure) and at T1 (1 month after the 1st injection treatment execution, before the 2nd aesthetic procedure);
•Body Mass Index (BMI) variation (± 1) during the study period;
•performing skin treatments for neck aesthetic correction (biomaterials implants, neck 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, neck cosmetic and cleansing 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 9 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

Profhilo®

Experimental

The 1st treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated after 1 month (T1).

2 mL of Profhilo® was injected into the middle-deep dermis by needle (29 G) using a bolus technique called "BAP" (Bio Aesthetic Point technique); this technique involves a series of 10 micro-wheals on 3 vertical-lines (3-4-3 ). The amount of product injected was 0.2 ml for each injection point.

干预措施: Profhilo® (Device)