New injectable filler aims to restore lost cheek volume
NCT ID NCT07710443
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Midface volume deficit are added.
By submitting, you agree to our Terms of use
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Bloom Facial Plastic & Aesthetic Surgery
RECRUITINGBryn Mawr, Pennsylvania, 19010, United States
-
Skin Fluence LLC
RECRUITINGHuntington Station, New York, 11746, United States
-
Skin Research Institute LLC
RECRUITINGCoral Gables, Florida, 33146, United States
-
SkinCare Physicians
RECRUITINGChestnut Hill, Massachusetts, 02467, United States
-
Weinkle Dermatology
RECRUITINGBradenton, Florida, 34209, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.