Clinical Trial

Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit

Study acronym: PRIME
Not Yet Recruiting
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Summary
The goal of this clinical trial is to study whether the Mosaic Injectable Dermal Implant is a safe and effective treatment for age-related midface volume deficit in adults who are at least 22 years of age. The main questions it aims to answer are: 1. What medical problems do participants have when receiving Mosaic over the 12 months following treatment. 2. How much does Mosaic improve the midface volume at 6 months post-treatment. Participants will: Receive injections to the midface to correct volume deficit. One month from initial injection, if the doctor decides that touch-up injections are required, further injections may be received. Participants will visit the clinic following each injection and at 3, 6 and 12 months post-treatment to have photos taken of their face as a record of their midface volume. Participants will also keep a diary for 30 days following each treatment so that they can record any symptoms that may be linked to the treatment.
Trial Details
NCT Number NCT07710443
Lead Sponsor Helios Aesthetics Inc.
Conditions Midface Volume Deficit
Enrollment 50 participants
Start Date 2026-09-08
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-17