Evaluating the safety and feasibility of Adipearl for mid-face volume deficiency
A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects
This study tests if the injectable filler Adipearl is safe and works well for people aged 22 to 65 who have volume loss in their mid-face.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | Volumina Medical S.A. Industry-sponsored |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06034522 on ClinicalTrials.gov |
What this trial studies
This clinical investigation focuses on the injectable filler Adipearl, which is designed for subcutaneous injection in the mid-face area to address volume deficiency. The study aims to assess the safety and feasibility of this treatment in a controlled setting. Participants will be evaluated based on their medical fitness and ability to provide informed consent. The study will include both male and female subjects aged 22 to 65 years.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 22 to 65 who are experiencing mid-face volume deficiency.
Not a fit: Patients who are pregnant, nursing, or planning a pregnancy, as well as those with conditions that prevent them from completing the study, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients seeking to restore facial volume and improve aesthetic appearance.
How similar studies have performed: While this specific approach is novel, similar injectable fillers have shown success in other studies for facial volume restoration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stockholm
- Art Clinic — Stockholm, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.