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Effectiveness and Safety of Cellbooster Shape in Healthy Subjects

3 de junio de 2026 actualizado por: 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).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Francia
      • Villeurbanne, Francia, 69100
        • Reclutamiento
        • Eurofins DERMSCAN PHARMASCAN
        • Contacto:
        • Investigador principal:
          • Patricia Morel, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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).
Dispositivo: 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).
Otros nombres:
  • Skin rejuvenation injection
  • Mesotherapy injection
  • Hyaluronic acid skin booster

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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).
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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)
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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.
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: Day 42 and Day 70
Day 42 and Day 70
Change from baseline of skin elasticity measured with Cutometer® at D42 and D70.
Periodo de tiempo: D42 and D70
D42 and D70
Change from baseline of epidermis hydration measured with Corneometer® at D42 and D70.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: Day 0 to Day 70
Day 0 to Day 70

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Suisselle

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de marzo de 2026

Finalización primaria (Estimado)

25 de agosto de 2026

Finalización del estudio (Estimado)

25 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

17 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

9 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUU524AA2269 / 24-2269-U5
  • 2025-A02508-41 (Otro identificador: ANSM)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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