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Effectiveness and Safety of Cellbooster Shape in Healthy Subjects

2026年6月3日 更新者：Suisselle

A Prospective, Open-label Study on the Effectiveness and Safety of Cellbooster® Shape (Stabilized Booster Complex Using CHAC Technology) on Healthy Subjects.

SUISSELLE has developed a CE marketed (2021) HA-based superficial epidermis/dermis injection filler and skinbooster product, Cellbooster® Shape (CBS). CBS is produced using patented CHAC Technology. It consists of non-crosslinked HA with L-Carnitine and vitamin C. The device is particularly designed for reducing local puffiness by improving microcirculation and hydration.

The current post-market clinical investigation is designed to evaluate the efficacy and safety of CBS. For this purpose, healthy subjects with signs of skin aging in the face will receive a 3-session treatment and will be followed-up over 70 days after the initial injection session.

Several objective measurements of skin quality will be performed with different instruments allowing to assess skin volume, skin elasticity, skin hydration, and skin microcirculation. Subjective clinical improvement will be evaluated, as well as subject and investigator satisfactions.

The safety of the injections will be assessed by collecting the Injection Site Reactions (ISRs) and Adverse Events (AEs).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

A prospective, open-label study on the effectiveness and safety of CellBooster® Shape (stabilized booster complex using CHAC technology) on healthy subjects. Single centre, prospective, open, before/after treatment, non comparative clinical investigation.

Primary objective:

To evaluate CellBooster® Shape (CBS) effectiveness on clinical Global Aesthetic Improvement, using the Global Aesthetic Improvement Scale (GAIS) evaluated by the investigator at D42.

Secondary objectives:

- To evaluate CBS effectiveness on clinical Global Aesthetic Improvement, using GAIS evaluated by the investigator at D70.

To evaluate CBS effectiveness on clinical Global Aesthetic Improvement, using GAIS evaluated by the subject at D42 and D70.

  • To evaluate the satisfaction of the injectors with CBS treatment using a subjective evaluation questionnaire after each injection session (D0, D14 and D28).
  • To evaluate the satisfaction of the subjects with CBS treatment using a subjective evaluation questionnaire at D42 and D70.
  • To illustrate CBS aesthetic effect through 2D photographies throughout the study period.
  • To evaluate CBS effectiveness of the improvement of skin quality by measurements of skin volume, microcirculation, elasticity, and hydration.
  • To evaluate CBS safety throughout the study period by ISRs evaluated by subject and investigator and AEs collection.

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

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:

  1. Healthy subject.
  2. Sex: male and female.
  3. Phototype II to IV.
  4. Age: from 35 years old.
  5. Subject with light to moderate signs of cutaneous ageing of the face.
  6. Subject with a skin hydration rate on cheekbones < 60 UA, measured with Corneometer®.
  7. Subject with light to moderate localized submental (double chin) and/or malar puffiness (at least 35 in each indication).
  8. Subject looking for an anti-age improvement using an aesthetic procedure.
  9. Subject willing to abstain from other facial aesthetic procedure in the full face through the entire study duration.
  10. Subject having given their free, express, and informed consent.
  11. Subject psychologically able to understand the information related to the study, and to give their written informed consent.
  12. Subject registered to a social security scheme.
  13. Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study.
  14. Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.

Exclusion Criteria:

In terms of population

  1. Pregnant or nursing woman or planning a pregnancy during the study.
  2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
  3. Subject in a social or sanitary establishment.
  4. Subject participating to another research on human beings or being in an exclusion period for a previous study.
  5. Subject having received a total of 6.000 euros as compensation for their participation in research involving human beings in the last 12 months, including their participation in the present study.
  6. Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study.

In terms of associated pathology 17. Subject with ongoing uncontrolled depression and/or recently recovered (<6 months) or psychiatric disorders or any other disorder that may pose a health risk to the subject in the study and/or may have an impact on the study assessments, at the investigator appreciation. 18. Subject with severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease, neoplasia, malignant blood disease, tumor, HIV, or other major disease (e.g., systemic fungal infection). 19. Subject with recurrent porphyria, coronary insufficiency, ventricular rhythm disorders, severe hypertension, obstructive cardiomyopathy, hyperthyroidism.

20. Subject with any skin or systemic disease (acute and/or chronic) likely to interfere with the measured parameters or to put the subject to an undue risk.

21. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.

22. Subject with current cutaneous inflammatory or infectious processes (e.g., acne, herpes, mycosis, papilloma, chronic eczema, atopic dermatitis &), abscess, unhealed wound, or a cancerous or precancerous lesion on the face.

23. Subject with multiple severe allergies history, anaphylactic shock history, quincke's oedema, evolutive allergic pathologies.

24. Subject having history of allergy or hypersensitivity to one of the components of the tested device.

25. Subject having history of hypersensitivity to the antiseptic solution, to lidocaine and/or prilocaine or local anesthetics of amide type or one of the excipients of EMLA 5% cream.

26. Subject predisposed to keloids or hypertrophic scarring. 27. Subject with coagulation and/or homeostasis disorders. 28. Subject with pigmentation disorders (vitiligo, melasma).

Related to previous or ongoing treatment 29. Subject under anti-coagulant treatment (such as aspirin, nonsteroidal anti-inflammatory drugs) or treatment liable to interfere with the healing process or hemostasis, during the previous month before injection and during the study.

30. Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.

31. Subject having received a COVID vaccination within the past 3 weeks prior to the injection or planning to receive one within the 2 weeks following injection.

32. Subject undergoing a topical (on the face) or systemic treatment:

  • anti-inflammatory medication during the previous 2 weeks and during the study.
  • anti-histaminics during the previous 7 days.
  • immunosuppressors and/or corticoids during the 4 previous weeks and during the study
  • retinoids during the 6 previous months and during the study

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：Experimental: CellBooster® Shape facial injection
  • a volume of 3mL of CBS will be injected in the dermis on the medium and lower third of the face (except nose and forehead).
  • a maximal volume of 9mL of CBS will be injected subcutaneously into maximum 3 puffiness pad zones, defined by the investigator : double-chin and/or malar puffiness zones (mandatory, and in option nasolabial puffiness and/or periocular puffiness).
デバイス：Skin booster injection (CBS)
Three injection sessions with an interval of 2 weeks between each session. An initial injection session will be performed at visit 2 (D0). A second injection session will be performed at visit 3 (D14). And a third injection session will be performed at visit 4 (D28).
他の名前：
  • Skin rejuvenation injection
  • Mesotherapy injection
  • Hyaluronic acid skin booster

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
Proportion of subjects having an improvement with Cellbooster Shape (CBS) treatment as assessed by the investigator at Day 42, using the Global Aesthetic Improvement Scale (GAIS).
時間枠：Day 42

A responder will be defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.

An improvement is defined as subject having a score "very much improved", "much improved" or "improved" on the GAIS.
Day 42

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of subjects having an improvement with Cellbooster Shape (CBS) treatment as assessed by the investigator at Day 70, using the Global Aesthetic Improvement Scale (GAIS)
時間枠：Day 70

A responder will be defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.

An improvement is defined as subject having a score "very much improved", "much improved" or "improved" on the GAIS.
Day 70
Proportion of subjects having an improvement with Cellbooster Shape (CBS) treatment as assessed by the subject, at Day 42 and Day 70, using the Global Aesthetic Improvement Scale (GAIS).
時間枠：Day 42 and Day 70
A responder will be defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS. An improvement is defined as subject having a score "very much improved", "much improved" or "improved" on the GAIS.
Day 42 and Day 70
Degree of satisfaction of the injectors through the answers to a subjective evaluation questionnaire completed for each subject after each injection session (Day 0, Day 14 and Day 28).
時間枠：Day 0, Day 14 and Day 28

The subjective evaluation by the injector is determined using a 5-point scale from "Very satisfied" to "Very dissatisfied".

For each question, the percentage of answers "satisfied" or "very satisfied" will be computed.
Day 0, Day 14 and Day 28
Degree of satisfaction of the subjects through the answers to a subjective evaluation questionnaire at Day 42 and Day 70.
時間枠：Day 42 and Day 70
The degree of satisfaction of the subjects will be collected using a subjective evaluation questionnaire of 21 questions. Satisfaction degree will be assessed from the five possible answers: "Not at all", "A little", "A lot", "Totally", "Not Applicable".
Day 42 and Day 70
Illustration of the aesthetic effect with photos of the whole face (front face profiles)
時間枠：Day 0, Day 42 and Day 70.
Day 0, Day 42 and Day 70.
Change from baseline of skin volume will be measured with DermaTop® at Day 42 and Day 70.
時間枠：Day 42 and Day 70
Day 42 and Day 70
Change from baseline of skin microcirculation measured with Laser Doppler at Day 42 and Day 70.
時間枠：Day 42 and Day 70
Day 42 and Day 70
Change from baseline of skin elasticity measured with Cutometer® at D42 and D70.
時間枠：D42 and D70
D42 and D70
Change from baseline of epidermis hydration measured with Corneometer® at D42 and D70.
時間枠：D42 and D70
D42 and D70
Evaluation of Injection Site Reactions (ISRs) by the investigator on the face, immediately after each injection session (D0, D14 and D28) and at D42 and D70.
時間枠：D0, D14, D28, D42 and D70
D0, D14, D28, D42 and D70
Evaluation of Injection Site Reactions (ISRs) by the subject on the face during 2 weeks after each injection session. Subject ISRs will be tabulated by maximum severity, and duration, after each injection session.
時間枠：Day 14, Day 28, Day 42

The proportion of subjects presenting the sign at least one time during the study will be computed globally and per sign.

For each sign and each injection, the mean duration will be computed for each subject. These outcomes will be summarized using descriptive statistics for quantitative data (for each post injection period).
Day 14, Day 28, Day 42
Collection of adverse events (AEs) and concomitant treatments during the study
時間枠：Day 0 to Day 70
Day 0 to Day 70

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

Suisselle

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 (実際)

2026年3月31日

一次修了 (推定)

2026年8月25日

研究の完了 (推定)

2026年8月25日

試験登録日

最初に提出

2026年4月17日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月9日

QC基準を満たした最後の更新が送信されました

2026年6月3日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STUU524AA2269 / 24-2269-U5
  • 2025-A02508-41 (その他の識別子：ANSM)

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?

いいえ

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

いいえ

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