Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit
Part of paid clinical trials in Bradenton, Florida.
- Sponsor
- Helios Aesthetics Inc.
- Study ID
- NCT07710443
- Status
- Not Yet Recruiting
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Conditions
- Midface Volume Deficit
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Injectable dermal implant — DEVICEMosaic 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
- Jul 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 midfaceUp 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 Officer339-707-7788
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Weinkle Dermatology | Bradenton | Florida | 34209 | Susan Weinkle, MD (PRINCIPAL_INVESTIGATOR) |
| Skin Research Institute LLC | Coral Gables | Florida | 33146 | Jeremy Green, MD (PRINCIPAL_INVESTIGATOR) Joely Kaufman, MD (SUB_INVESTIGATOR) |
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | Michael Kaminer, MD (PRINCIPAL_INVESTIGATOR) Mitalee Christman, MD (SUB_INVESTIGATOR) |
| Skin Fluence LLC | Huntington Station | New York | 11746 | Andrew Peredo, MD (PRINCIPAL_INVESTIGATOR) |
| Bloom Facial Plastic & Aesthetic Surgery | Bryn Mawr | Pennsylvania | 19010 | Jason Bloom, MD (PRINCIPAL_INVESTIGATOR) Julie Shtraks, MD (SUB_INVESTIGATOR) |