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

13 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Florida
      • Bradenton, Florida, Stati Uniti, 34209
        • Weinkle Dermatology
        • Contatto:
        • Investigatore principale:
          • Susan Weinkle, MD
      • Coral Gables, Florida, Stati Uniti, 33146
        • Skin Research Institute LLC
        • Contatto:
        • Investigatore principale:
          • Jeremy Green, MD
        • Sub-investigatore:
          • Joely Kaufman, MD
    • Massachusetts
      • Chestnut Hill, Massachusetts, Stati Uniti, 02467
        • SkinCare Physicians
        • Contatto:
        • Investigatore principale:
          • Michael Kaminer, MD
        • Sub-investigatore:
          • Mitalee Christman, MD
    • New York
      • Huntington Station, New York, Stati Uniti, 11746
        • Skin Fluence LLC
        • Contatto:
        • Investigatore principale:
          • Andrew Peredo, MD
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Stati Uniti, 19010
        • Bloom Facial Plastic & Aesthetic Surgery
        • Contatto:
        • Investigatore principale:
          • Jason Bloom, MD
        • Sub-investigatore:
          • Julie Shtraks, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: Injectable dermal implant
Mosaic Injectable Dermal Implant (1 mL syringes)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effectiveness of Mosaic determined by comparing the independent CMVDS scores of the left and right sides of the face
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Helios Aesthetics Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 settembre 2026

Completamento primario (Stimato)

31 gennaio 2028

Completamento dello studio (Stimato)

31 gennaio 2028

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • CIP001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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