Skin AgingNCT07636512
Effectiveness and Safety of Cellbooster Shape in Healthy Subjects
A study testing Skin booster injection (CBS) in people with Skin Aging, run by Suisselle at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Skin booster injection (CBS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2026to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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®.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Eurofins Dermscan Pharmascan
Villeurbanne, 69100
Patricia Morel, MD, +33 (0) 4 72 82 36 56, Patricia.MOREL-MANDRINO@cpt.eurofinseu.com
Patricia Morel, MD
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Skin Aging
- Being tested
- Skin booster injection (CBS)
- Keywords
- Skin aging, Facial aging, Hyaluronic acid, Dermal injection, Skin hydration, Skin elasticity, Microcirculation, Facial puffiness, Global Aesthetic Improvement Scale, Subcutaneous injection, Patient satisfaction, Submental, Periocular, Nasolabial fold, Skin rejuvenation, skin booster, Double chin, Cellbooster, Cellbooster Shape, Fat pad
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin booster injection (CBS)Device
Also called Skin rejuvenation injection, Mesotherapy injection, Hyaluronic acid skin booster
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CellBooster® Shape facial injection | Experimental | * 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). Receives: Device: Skin booster injection (CBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: Day 42
Secondary outcomes (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)
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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.
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".
Measured: Day 42 and Day 70
Illustration of the aesthetic effect with photos of the whole face (front face profiles)
Measured: Day 0, Day 42 and Day 70.
Change from baseline of skin volume will be measured with DermaTop® at Day 42 and Day 70.
Measured: Day 42 and Day 70
Change from baseline of skin microcirculation measured with Laser Doppler at Day 42 and Day 70.
Measured: Day 42 and Day 70
Change from baseline of skin elasticity measured with Cutometer® at D42 and D70.
Measured: D42 and D70
Change from baseline of epidermis hydration measured with Corneometer® at D42 and D70.
Measured: 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.
Measured: 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.
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).
Measured: Day 14, Day 28, Day 42
Collection of adverse events (AEs) and concomitant treatments during the study
Measured: Day 0 to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start31 Mar 2026
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suisselle
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636512
- Sponsor's protocol ID
- STUU524AA2269 / 24-2269-U5
- Other IDs
- 2025-A02508-41
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Study on the Effectiveness and Safety of Cellbooster® Shape (Stabilized Booster Complex Using CHAC Technology) on Healthy Subjects.
- ClinicalTrials.gov ID
- NCT07636512
- Acronym / sponsor ID
- STUU524AA2269 / 24-2269-U5
- Conditions
- Skin Aging
- Keywords
- Skin aging, Facial aging, Hyaluronic acid, Dermal injection, Skin hydration, Skin elasticity, Microcirculation, Facial puffiness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SuisselleIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: CellBooster® Shape facial injection | Experimental | Device: Skin booster injection (CBS)* 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). |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin booster injection (CBS)Also: Skin rejuvenation injection, Mesotherapy injection, Hyaluronic acid skin boosterThree 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). | Device | Experimental: CellBooster® Shape facial injection |
Primary outcome
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
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin booster injection (CBS) in people with Skin Aging, run by Suisselle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Nguon, PhD (+41 78 320 90 92, nina.nguon@suisselle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.