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

2026년 7월 13일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: Injectable dermal implant
Mosaic Injectable Dermal Implant (1 mL syringes)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Effectiveness of Mosaic determined by comparing the independent CMVDS scores of the left and right sides of the face
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Helios Aesthetics Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 8일

기본 완료 (추정된)

2028년 1월 31일

연구 완료 (추정된)

2028년 1월 31일

연구 등록 날짜

최초 제출

2026년 7월 8일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • CIP001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

중간면 볼륨 적자에 대한 임상 시험

  • National Taiwan University Hospital
    모병
    TVC 응답을 위한 VIP
    Tidal Volume Challenge Test에서 PVI 검증
    대만

Injectable dermal implant에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Myanmar

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다