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

NCT07710443 | Not Yet Recruiting FDA Device

• 1 other identifier: CIP001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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. 1.What medical problems do participants have when receiving Mosaic over the 12 months following treatment.
2. 2.How much does Mosaic improve the midface volume at 6 months post-treatment.

Conditions

Midface Volume Deficit

Keywords

Mosaic; dermal filler; dermal implant; dermal aesthetics; injectable

Outcome Measures

Primary Outcomes (2)

• 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.

  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".

  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

  3 months (supportive), 6 months (definitive), and 12 months (durability / persistence of effect) post-treatment

Study Arms (1)

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.

Device: Injectable dermal implant

Interventions

Injectable dermal implant DEVICE

Mosaic Injectable Dermal Implant (1 mL syringes)

Mosaic injection(s) to midface

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helios Aesthetics Inc.: lead

Study Sites (5)

Weinkle Dermatology

Bradenton, Florida, 34209, United States

Location

Skin Research Institute LLC

Coral Gables, Florida, 33146, United States

Location

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Skin Fluence LLC

Huntington Station, New York, 11746, United States

Location

Bloom Facial Plastic & Aesthetic Surgery

Bryn Mawr, Pennsylvania, 19010, United States

Location

Central Study Contacts

Chief Operations Officer

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 8, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (5)