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

Conditions

• Midface Volume Deficit

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Injectable dermal implant — DEVICE
  Mosaic Injectable Dermal Implant (1 mL syringes)

Study Details

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.

Key Dates

First listed

Jul 17, 2026

Start date

Sep 8, 2026

Status verified

Aug 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Mosaic injection(s) to midface
  Up to 12 mL of Mosaic Injectable Dermal Implant spread over two interventions (maximum 6 mL in each intervention) spaced 1 month apart.

Primary Outcome Measure

The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Through study completion, an average of 13 months ]

Central Contacts

• Chief Operations Officer
  339-707-7788
  [email protected]

Locations (5)

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