New injectable filler aims to restore lost cheek volume

NCT ID NCT07710443

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tests whether Mosaic, an injectable dermal implant, can safely and effectively treat age-related volume loss in the midface (cheek area). Adults aged 22 and older with moderate to severe volume loss receive injections, with possible touch-ups after one month. Researchers track side effects and measure improvement in cheek fullness over 6 to 12 months using photos and patient diaries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mosaic Injectable Dermal Implant (a dermal filler injected into the midface)
What this could lead to
If successful, this could offer a new option for restoring lost volume in the cheeks and midface, potentially improving facial appearance and satisfaction.
What could go wrong
This is a small, early pilot study with no control group, so results may not prove effectiveness. Common risks include bruising, swelling, and lumps at injection sites.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Bloom Facial Plastic & Aesthetic Surgery

    RECRUITING

    Bryn Mawr, Pennsylvania, 19010, United States

  • Skin Fluence LLC

    RECRUITING

    Huntington Station, New York, 11746, United States

  • Skin Research Institute LLC

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • SkinCare Physicians

    RECRUITING

    Chestnut Hill, Massachusetts, 02467, United States

  • Weinkle Dermatology

    RECRUITING

    Bradenton, Florida, 34209, United States

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