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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Mosaic Injectable Dermal Implant (1 mL syringes)
Weinkle Dermatology
Bradenton, Florida, United States
RECRUITINGSkin Research Institute LLC
Coral Gables, Florida, United States
RECRUITINGSkinCare Physicians
Chestnut Hill, Massachusetts, United States
RECRUITINGSkin Fluence LLC
Huntington Station, New York, United States
RECRUITINGBloom Facial Plastic & Aesthetic Surgery
Bryn Mawr, Pennsylvania, United States
RECRUITINGThe 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.
Time frame: 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".
Time frame: Daily for 30 days post-intervention
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.
Time frame: 3 months (supportive), 6 months (definitive), and 12 months (durability / persistence of effect) post-treatment
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