Midface Volume DeficitPRIMENCT07710443
Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit
A study testing Injectable dermal implant in people with Midface Volume Deficit, run by Helios Aesthetics Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Midface Volume Deficit
- What is being tested?
- Injectable dermal implant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Sep 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Weinkle Dermatology
Bradenton, Florida, 34209
Michelle Haddock, 941-794-5432, mhaddock.weinklederm@gmail.com
Susan Weinkle, MD
- Recruiting
Bloom Facial Plastic & Aesthetic Surgery
Bryn Mawr, Pennsylvania, 19010
Sherri Hansell, 610-762-5666, shansell@bloomfps.com
Jason Bloom, MD
- Recruiting
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Joaninha Barbosa, 617-848-1641, jbarbosa@skincarephysicians.net
Michael Kaminer, MD
- Recruiting
Skin Research Institute LLC
Coral Gables, Florida, 33146
Alex Cazzaniga, 305-443-6606, acazzaniga@srinstitute.org
Jeremy Green, MD
- Recruiting
Skin Fluence LLC
Huntington Station, New York, 11746
Joanne Shellock, 212-754-6363, joanne@skinfluencenyc.com
Andrew Peredo, MD
About this study
Official title: 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:
- What medical problems do participants have when receiving Mosaic over the 12 months following treatment.
- How much does Mosaic improve the midface volume at 6 months post-treatment.
Read more
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
- Being tested
- Injectable dermal implant
- Keywords
- Mosaic, dermal filler, dermal implant, dermal aesthetics, injectable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable dermal implantDevice
Mosaic Injectable Dermal Implant (1 mL syringes)
| Study group | Role | What they receive |
|---|---|---|
| Mosaic injection(s) to midface | Experimental | Up to 12 mL of Mosaic Injectable Dermal Implant spread over two interventions (maximum 6 mL in each intervention) spaced 1 month apart. Receives: Device: Injectable dermal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).
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.
Measured: Through study completion, an average of 13 months
Patient Diary Recorded Events
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".
Measured: Daily for 30 days post-intervention
Secondary outcomes (1)
Effectiveness of Mosaic determined by comparing the independent CMVDS scores of the left and right sides of the face
Effectiveness of Mosaic determined by comparing the independent CMVDS scale scores of the left and right sides of the face obtained at baseline to the scores . For each subject, success is defined as a 1-grade or greater improvement on both the left and right sides of the face independently on the CMVDS, as assessed by a blinded, independent panel of at least three (3) physicians trained in the application of the scale.
Measured: 3 months (supportive), 6 months (definitive), and 12 months (durability / persistence of effect) post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start8 Sep 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midface Volume DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Aesthetics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710443
- Sponsor's protocol ID
- CIP001
- Acronym
- PRIME
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Pilot Study Evaluating the Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit
- ClinicalTrials.gov ID
- NCT07710443
- Acronym / sponsor ID
- PRIME / CIP001
- Conditions
- Midface Volume Deficit
- Keywords
- Mosaic, dermal filler, dermal implant, dermal aesthetics, injectable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helios Aesthetics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What medical problems do participants have when receiving Mosaic over the 12 months following treatment.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mosaic injection(s) to midface | Experimental | Device: Injectable dermal implantUp to 12 mL of Mosaic Injectable Dermal Implant spread over two interventions (maximum 6 mL in each intervention) spaced 1 month apart. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable dermal implantMosaic Injectable Dermal Implant (1 mL syringes) | Device | Mosaic injection(s) to midface |
Primary outcome
The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).
Time frame: 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 Events
Time frame: Daily 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".
1 secondary outcome
Effectiveness of Mosaic determined by comparing the independent CMVDS scores of the left and right sides of the face
Time frame: 3 months (supportive), 6 months (definitive), and 12 months (durability / persistence of effect) post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable dermal implant in people with Midface Volume Deficit, run by Helios Aesthetics Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Operations Officer (339-707-7788, clinical-research@heliosaesthetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.