Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit (PRIME)

21 augustus 2026 bijgewerkt door: Helios Aesthetics Inc.

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:

  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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Florida
      • Bradenton, Florida, Verenigde Staten, 34209
        • Werving
        • Weinkle Dermatology
        • Contact:
        • Hoofdonderzoeker:
          • Susan Weinkle, MD
      • Coral Gables, Florida, Verenigde Staten, 33146
        • Werving
        • Skin Research Institute LLC
        • Contact:
        • Hoofdonderzoeker:
          • Jeremy Green, MD
        • Onderonderzoeker:
          • Joely Kaufman, MD
    • Massachusetts
      • Chestnut Hill, Massachusetts, Verenigde Staten, 02467
        • Werving
        • SkinCare Physicians
        • Contact:
        • Hoofdonderzoeker:
          • Michael Kaminer, MD
        • Onderonderzoeker:
          • Mitalee Christman, MD
    • New York
      • Huntington Station, New York, Verenigde Staten, 11746
        • Werving
        • Skin Fluence LLC
        • Contact:
        • Hoofdonderzoeker:
          • Andrew Peredo, MD
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Verenigde Staten, 19010
        • Werving
        • Bloom Facial Plastic & Aesthetic Surgery
        • Contact:
        • Hoofdonderzoeker:
          • Jason Bloom, MD
        • Onderonderzoeker:
          • Julie Shtraks, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Injectable dermal implant
Mosaic Injectable Dermal Implant (1 mL syringes)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).
Tijdsspanne: 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.
Through study completion, an average of 13 months
Patient Diary Recorded Events
Tijdsspanne: 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".
Daily for 30 days post-intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness of Mosaic determined by comparing the independent CMVDS scores of the left and right sides of the face
Tijdsspanne: 3 months (supportive), 6 months (definitive), and 12 months (durability / persistence of effect) post-treatment
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.
3 months (supportive), 6 months (definitive), and 12 months (durability / persistence of effect) post-treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Helios Aesthetics Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

8 september 2026

Primaire voltooiing (Geschat)

31 januari 2028

Studie voltooiing (Geschat)

31 januari 2028

Studieregistratiedata

Eerst ingediend

8 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 juli 2026

Eerst geplaatst (Werkelijk)

17 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

21 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • CIP001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren