A prospective clinical multicenter study to evaluate the safety, performance and subject satisfaction when using hyaluronic acid fillers from the Mona Lisa product range by GENOSS to build facial volume and contour the face and their comparison to products from the manufacturers Across, Allergan, Galderma and Vivacy

GENOSS0 个研究点目标入组 700 人开始时间: 2024年3月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Aesthetic desire to increase volume or emphasize the contours of the face
•- Female participants aged 18 years or older
•- Subjects who would also have been treated outside the study with a hyaluronic acid gel intended for the region.
•- Injection on both sides and on the same sides
•- Legal capacity as well as the existence of written consent to participate in the study, the data protection declaration as well as the signed information form and consent to photo documentation after detailed information and advice

•- Additional injections of the same region within the testing period
•- History of hypersensitivity or allergy to hyaluronic acid, its ingredients or to products with a similar chemical structure
•- Known hypersensitivity or allergy to lidocaine or products of the same substance class
•- Known hypersensitivity to gram-positive bacteria
•- Tendency to hypertrophic scars or keloid formation
•- Subject with active inflammatory process or infectious event
•- Subject suffering from a serious acute or chronic disease
•- Taking blood thinning medications
•- Scars in the area to be treated
•- Excessive excess skin in the area to be treated
•- Inadequate tissue coverage in the area to be treated
•- insufficient capacity of the tissue to inject the intended amount
•- BMI <18 or unstable weight
•- Rapid Metabolizer (participants with accelerated breakdown of hyaluronic acid gels)
•- Subjects during pregnancy or breastfeeding
•- Subjects who show low compliance (willingness to cooperate) to cooperate with treatment or other planned measures of the study
•- Subjects who have been vaccinated in the past four weeks
•- Subjects who refuse the declaration of consent to participate in the study, the information form, the consent to photo documentation and the data protection declaration

发起方

GENOSS