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Mosaic Injectable Dermal Implant for Midface Volume Deficit

This study is testing the Mosaic Injectable Dermal Implant to see if it's a safe and effective treatment for age-related midface volume deficit (a loss of fullness in the middle part of your face). We want to understand what medical problems participants might experience over 12 months after treatment and how much Mosaic improves midface volume after 6 months. You might be able to join if you are at least 22 years old and have moderate or severe volume loss on both sides of your midface. The study is currently enrolling about 50 participants.

Study design
This is an interventional study planning to enroll 50 participants.
What's involved
You will receive injections to your midface. One month after the first injection, you may receive additional 'touch-up' injections if your doctor decides they are needed.
Compensation
Not stated in the trial record.
Follow-up
Your medical problems will be tracked for about 13 months, and you will record daily events in a diary for 30 days after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07710443

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

Not Yet Recruiting
NAAges 22+InterventionalTreatment
Helios Aesthetics Inc.
~50 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Injectable dermal implant

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).
Measured over Through study completion, an average of 13 months
+1 more outcome measured

Conditions

Midface Volume Deficit

Explore related trials

Midface Volume Deficit

Where it's being run

5 sites across 4 states
Florida2
Massachusetts1
New York1
Pennsylvania1

Who to contact

Chief Operations Officer
[email protected]
339-707-7788
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).Through study completion, an average of 13 months

    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.

  • Patient Diary Recorded EventsDaily for 30 days post-intervention

    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".