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

Open Label Pilot Study Evaluating the Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit

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.

Inclusion Criteria:

Subjects:

• Who at baseline, demonstrate bilateral and symmetrical volume deficit in their midface of grades moderate or severe on the CMVDS based upon live image scoring (i.e., both the left and right sides of the face must be graded independently, and both sides must score grades of either moderate or severe to be eligible)..
• Who, if male, agree to be clean-shaven at each study visit.

Exclusion Criteria:

Subjects:

• Who are an employee or relative of an employee of the clinical site or study sponsor (e.g., immediate family, household members).
• Who may have any physical attributes such as skin lesions, tattoos, or other issues in the midface that may, in the investigator's judgment, interfere with effectiveness assessments or study treatments.
• With active skin disease within the past 6 months or with a history of precancerous lesion or skin malignancies in the midface that may, in the investigator's judgment, interfere with effectiveness assessments or study treatments.
• With a known allergy to any of the components of Mosaic, including hyaluronic acid, lidocaine, and bovine collagen.
• With a history of hypertrophic scarring and/or keloid scarring.
• With active autoimmune disease.
• With a history of anaphylactic shock.
• Who are taking any anticoagulation therapy or medications which may increase bleeding including warfarin and DOACS within 7 days of any treatment.
• Who have a history of a coagulation disorder.
• Who are using prescription topical and/or systemic steroids within 30 days of enrollment or who are planning to use such products during the study.
• Who have a history of a dietary beef allergy, or who are undergoing desensitization to beef products, or who are planning to undergo desensitization during the study period.
• With a history of alpha-gal syndrome or a history of a Lone Star tick bite.
• With infected or unhealed wounds on the midface.
• Who have received any neurotoxin injections into the orbicularis oculi region, the midface, or the lower face within the past 6 months.
• Who have received any non-permanent fillers (e.g. hyaluronic acid injections) into the orbicularis oculi region, the midface, or the lower face within the past 12 months.
• Who have received any long duration non-permanent fillers (e.g., Juvederm Voluma) into the orbicularis oculi region, the midface, or the lower face within the past 24 months.
• Who have ever received any permanent (non-biodegradable) fillers (e.g., polymethylmethacrylate (PMMA) or silicone injections), lifting treads, permanent implants or autologous fat into the orbicularis oculi region, the midface, or the lower face.
• Who have received a semi-permanent filler (e.g., poly-L-lactic acid (PLLA), or calciumhydroxylapatite (CaHA)) into the orbicularis oculi region, the midface, or the lower face during the past 24 months.
• Who have received dermal resurfacing procedures, non-invasive skin tightening procedures, or energy-based or mechanical/chemical aesthetic procedures on the midface within the past 6 months.
• Who have used systemic retinoids within the past 6 months.
• Who have ever had any prior facial plastic surgery, face or midface lifts, thread lifting procedures, or autologous fat injections to the midface.
• With abnormal visual acuity (e.g., subjects with visual acuity less than 20/40 in either eye with or without corrective lenses), abnormal confrontational visual fields, and abnormal ocular motility.
• Who are pregnant, planning to get pregnant during the study, or are breastfeeding.
• Who do not agree to use and stay on an approved method of birth control including IUD or hormone therapy (unless they have been postmenopausal for at least one year or have had a hysterectomy or tubal ligation).
• Who are planning to undergo major facial or oral surgery during the study.
• Who had major oral or maxillofacial surgery within the past 12 months.
• Who have received any vaccine within two weeks prior to the anticipated treatment visit, or who plan to receive a vaccine within two weeks after treatment.
• Who have had a severe viral or bacterial illness, infection, or major dental procedure within two weeks prior to the anticipated treatment visit.
• Who exhibit a positive SRT result during the Screening Phase, defined as EITHER a Positive or Equivocal Response during the 28-day observation period OR a positive anti-bovine type I collagen IgG ELISA serology test at Day 28.