このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年8月21日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Florida
      • Bradenton、Florida、アメリカ、34209
        • 募集
        • Weinkle Dermatology
        • コンタクト：
        • 主任研究者：
          • Susan Weinkle, MD
      • Coral Gables、Florida、アメリカ、33146
        • 募集
        • Skin Research Institute LLC
        • コンタクト：
        • 主任研究者：
          • Jeremy Green, MD
        • 副調査官：
          • Joely Kaufman, MD
    • Massachusetts
      • Chestnut Hill、Massachusetts、アメリカ、02467
        • 募集
        • SkinCare Physicians
        • コンタクト：
        • 主任研究者：
          • Michael Kaminer, MD
        • 副調査官：
          • Mitalee Christman, MD
    • New York
      • Huntington Station、New York、アメリカ、11746
        • 募集
        • Skin Fluence LLC
        • コンタクト：
        • 主任研究者：
          • Andrew Peredo, MD
    • Pennsylvania
      • Bryn Mawr、Pennsylvania、アメリカ、19010
        • 募集
        • Bloom Facial Plastic & Aesthetic Surgery
        • コンタクト：
        • 主任研究者：
          • Jason Bloom, MD
        • 副調査官：
          • Julie Shtraks, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：Injectable dermal implant
Mosaic Injectable Dermal Implant (1 mL syringes)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
The incidence, intensity, duration and onset adverse events (AEs) and serious adverse events (SAEs).
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Effectiveness of Mosaic determined by comparing the independent CMVDS scores of the left and right sides of the face
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Helios Aesthetics Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月8日

一次修了 (推定)

2028年1月31日

研究の完了 (推定)

2028年1月31日

試験登録日

最初に提出

2026年7月8日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月24日

QC基準を満たした最後の更新が送信されました

2026年8月21日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • CIP001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する