Effectiveness and Safety of Cellbooster Shape in Healthy Subjects

Official title

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

Overview

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).

Detailed description

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.

Interventions

• Device 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).

Primary outcome measures

• 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). [Time frame: Day 42]

Secondary outcome measures (12)

• 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) [Time frame: 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). [Time frame: 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). [Time frame: 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. [Time frame: Day 42 and Day 70]
• Illustration of the aesthetic effect with photos of the whole face (front face profiles) [Time frame: Day 0, Day 42 and Day 70.]
• Change from baseline of skin volume will be measured with DermaTop® at Day 42 and Day 70. [Time frame: Day 42 and Day 70]
• Change from baseline of skin microcirculation measured with Laser Doppler at Day 42 and Day 70. [Time frame: Day 42 and Day 70]
• Change from baseline of skin elasticity measured with Cutometer® at D42 and D70. [Time frame: D42 and D70]
• Change from baseline of epidermis hydration measured with Corneometer® at D42 and D70. [Time frame: 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. [Time frame: 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. [Time frame: Day 14, Day 28, Day 42]
• Collection of adverse events (AEs) and concomitant treatments during the study [Time frame: Day 0 to Day 70]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

In terms of population

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• Subject participating to another research on human beings or being in an exclusion period for a previous study.
• 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.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• Eurofins Dermscan Pharmascan — Villeurbanne

Identifiers

NCT: NCT07636512 · STUU524AA2269 / 24-2269-U5 · 2025-A02508-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗