Evaluation of Safety of Filler Injection in Subcutaneous Tissues

Volumina Medical

Status: Active, not recruiting

Conditions: Face Volume Deficiency

Treatments: Device: Adipearl

Study type: Interventional

Funder types: Industry

Identifiers

NCT06322043

VM-APFB-1023

Details and patient eligibility

About

Adipearl is an injectable filler intended to be injected subcutaneously.

Enrollment: 18 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

Volume correction with Investigational Device

Experimental group

Description:

Subjects will be injected subcutaneously with the Investigational Device to correct volume deficiencies.

Treatment:

Device: Adipearl