Evaluation of Safety of Filler Injection in Subcutaneous Tissues

Launched by VOLUMINA MEDICAL S.A. · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a product called Adipearl, which is an injectable filler designed to improve areas of volume deficiency in the skin. The trial aims to see how well this filler works when injected under the skin. It is important for people who may be interested in joining the trial to know that it is not yet recruiting participants, meaning they haven't started enrolling anyone just yet.

To be eligible to participate, you need to be between 22 and 65 years old and be in good health as determined by the study doctor. Unfortunately, if you are pregnant, nursing, or planning to become pregnant, you won’t be able to join. Additionally, you can't take part if you are involved in another research study. If you do qualify and decide to participate, you can expect to receive the filler injection and be monitored for any side effects or reactions. This study is a chance to contribute to understanding how this new product works for people needing volume restoration in their skin.

Gender

ALL

Eligibility criteria

• 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.