Face Volume Deficiency
Conditions
Brief summary
Adipearl is an injectable filler intended to be injected subcutaneously.
Interventions
DEVICEAdipearl
Injection of the investigational device in subcutaneous tissue.
Sponsors
Volumina Medical S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject having given freely and expressly informed consent; * Subject deemed by the Investigator to be medically fit for injection of the product; * Female or male subjects aged 22 to 65 years (inclusive);
Exclusion criteria
* Pregnant or nursing woman or planning a pregnancy during the study. * Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. * Subject participating to another research study. * Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Investigational Medical Device | 6-Months | Collection of Injection Site Reactions and Adverse Events during the study. |
Countries
Switzerland
Outcome results
None listed