DRKS00033799
Not Yet Recruiting
N/A
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 sites700 target enrollmentMarch 5, 2024
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- hypovolaemia, hypotrophy, atrophy, loss of contour, excess skin
- Sponsor
- GENOSS
- Enrollment
- 700
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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