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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mosaic injection(s) to midface | Experimental | Up to 12 mL of Mosaic Injectable Dermal Implant spread over two interventions (maximum 6 mL in each intervention) spaced 1 month apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable dermal implant | Device | Mosaic Injectable Dermal Implant (1 mL syringes) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs). | The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs) throughout the entirety of the study. Safety evaluations will look at the frequency, severity, and causal relationship of AEs and SAEs. | Through study completion, an average of 13 months |
| Patient Diary Recorded Events | The incidence, intensity, and number of days of expected post-treatment events collected using 30 day subject diaries after each treatment session. These will include injection site responses from the following predefined list; bruising, swelling, redness, pain or tenderness, itching, lump or bump (new or worsening), hardness (new or worsening), numbness or tingling or other adverse events. Subjects will rate each potential treatment response listed on the diary as '"None", "Mild", "Moderate", or "Severe". | Daily for 30 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Mosaic determined by comparing the independent CMVDS scores of the left and right sides of the face | Effectiveness of Mosaic determined by comparing the independent CMVDS scale scores of the left and right sides of the face obtained at baseline to the scores . For each subject, success is defined as a 1-grade or greater improvement on both the left and right sides of the face independently on the CMVDS, as assessed by a blinded, independent panel of at least three (3) physicians trained in the application of the scale. |
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Inclusion Criteria:
Subjects:
Exclusion Criteria:
Subjects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Operations Officer | Contact | 339-707-7788 | clinical-research@heliosaesthetics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weinkle Dermatology | Bradenton | Florida | 34209 | United States |
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| 3 months (supportive), 6 months (definitive), and 12 months (durability / persistence of effect) post-treatment |
| Skin Research Institute LLC | Coral Gables | Florida | 33146 | United States |
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| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
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| Skin Fluence LLC | Huntington Station | New York | 11746 | United States |
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| Bloom Facial Plastic & Aesthetic Surgery | Bryn Mawr | Pennsylvania | 19010 | United States |
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