hypovolaemia, hypotrophy, atrophy, loss of contour, excess skin
Conditions
Interventions
Group 1: Filler of Mona Lisa GENOSS
Group 2: Filler of Across
Group 3: Filler of Allergan
Group 4: Filler of Galderma
Group 5: Filler of Vivacy
Sponsors
GENOSS
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion 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
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is subject satisfaction after 6 months, which is assessed by reporting the score on the GAIS (Global Aesthetic Improvement Scale) scale. Patients are asked to rate their satisfaction with the results of the injection on a scale of 1 to 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The value of the GAIS (Global Aesthetic Improvement Scale) scale of the study participants at all examination times - The value of the GAIS (Global Aesthetic Improvement Scale) scale of the (medical) observer at all examination times - The practitioner's satisfaction with the use of the above-mentioned products at all examination times - Occurrence of complications - Occurrence of pain | — |
Countries
Germany
Contacts
Public ContactParshanak Azdasht
B1 Medical
Outcome results
None listed