Recruiting

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

Sponsor:

Helios Aesthetics Inc.

Code:

NCT07710443

Conditions

Midface Volume Deficit

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Injectable dermal implant

Study Details

Brief summary:

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.

Conditions

Midface Volume Deficit

Study ID

NCT07710443

Start date

Sep 8, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mosaic injection(s) to midface

Up to 12 mL of Mosaic Injectable Dermal Implant spread over two interventions (maximum 6 mL in each intervention) spaced 1 month apart.

Interventions

Injectable dermal implant

Mosaic Injectable Dermal Implant (1 mL syringes)

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 ]
Patient Diary Recorded Events [ Time Frame: Daily for 30 days post-intervention ]

Central Contacts and Locations

Central contacts

Chief Operations Officer

339-707-7788 clinical-research@heliosaesthetics.com

Locations

Weinkle Dermatology

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Michelle Haddock

941-794-5432 mhaddock.weinklederm@gmail.com

Principal Investigator:

Susan Weinkle, MD

Skin Research Institute LLC

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Alex Cazzaniga

305-443-6606 acazzaniga@srinstitute.org

Principal Investigator:

Jeremy Green, MD

SkinCare Physicians

Recruiting

Chestnut Hill, Massachusetts, United States, 02467

Contacts

Joaninha Barbosa

617-848-1641 jbarbosa@skincarephysicians.net

Principal Investigator:

Michael Kaminer, MD

Skin Fluence LLC

Recruiting

Huntington Station, New York, United States, 11746

Contacts

Joanne Shellock

212-754-6363 joanne@skinfluencenyc.com

Principal Investigator:

Andrew Peredo, MD

Bloom Facial Plastic & Aesthetic Surgery

Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

Contacts

Sherri Hansell

610-762-5666 shansell@bloomfps.com

Principal Investigator:

Jason Bloom, MD

More Information

Sponsor

Helios Aesthetics Inc.

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

Mosaic
dermal filler
dermal implant
dermal aesthetics
injectable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Helios Aesthetics Inc. on 2026-08-24.