Effectiveness and Safety of Cellbooster Glow in Healthy Subjects

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

40 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

60 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The current post-market clinical investigation is designed to evaluate the efficacy and safety of Cellbooster Glow (CBG). For this purpose, healthy participants 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 wrinkles, elasticity, dryness, pigmentation, roughness, overall inflammation and microcirculation. Subjective clinical improvement will be evaluated, as well as participant and investigator satisfactions. The safety of the injections will be assessed by collecting the Injection Site Reactions (ISRs) and Adverse Events (AEs).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Healthy participant.
2. Sex: male and female.
3. Phototype II to IV.
4. Age: from 40 years old.
5. Participant with mild to moderate wrinkles on cheeks (score from 1 to 5 on Bazin cheek folds scale)
6. Participant with a skin hydration rate on cheekbones \< 60 UA, measured with Corneometer®.
7. Participant with dry skin, skin laxity and dull skin on face.
8. Participant with skin pigmented area (at least one pigmented spot)
9. Participant with pigmented dark circles
10. Participant agreeing to apply UV cream during all the study.
11. Participant looking for an anti-age improvement using an aesthetic procedure.
12. Participant willing to abstain from other facial aesthetic procedure in the full face through the entire study duration.
13. Participant having given their free, express, and informed consent.
14. Participant psychologically able to understand the information related to the study, and to give their written informed consent.
15. Participant registered to a social security scheme.
16. 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.
17. Female participants 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. Participant who had been deprived of their freedom by administrative or legal decision or who is under guardianship or curatorship.
3. Participant in a social or sanitary establishment.
4. Participant having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
5. Participant enrolled in another interventional clinical research or being in an exclusion period for a previous study.
6. Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study.
7. Participant with a tattoo, a scar, moles, too many hairs or anything on the face which may interfere with the study at the investigator appreciation.
8. Participant with inflammation or infection on the studied zone (face).
9. Participant with varices on the studied zone (face).
10. Participant having resorbable filling product (e.g., hyaluronic acid) injections, a laser treatment, an ultrasound-based treatment, a dermabrasion, a deep chemical peeling or other ablative procedure on the face within 12 months prior to study start and a facial surgery in the past 2 years.
11. Participant having received mesotherapy products in the face within the 6 previous months.
12. Participant having done a superficial or medium peeling or a superficial scrub on the face within the 2 previous months.
13. Participant using cosmetic products with alpha hydroxy acids (AHA) in the last 4 weeks and during all the study.
14. Participant with subcutaneous retaining structure resorbable or non-resorbable on the face (meshing, threads, gold strand).
15. Participant having received injections of permanent filling products (e.g., acrylate polymers, silicone, polytetrafluoroethylene) on the face.
16. Participant having received injections of semi-permanent filling product on the face (L-polylactic acid, Calcium Hydroxyapatite...) in the last 24 months.
17. Participant with an excessive consumption of alcohol (more than 2 glasses of wine per day, 500mL of beer or 60mL of spirits) and/or tobacco (more than 10 cigarettes per day) and no change this habit during the study.
18. Participant having used oral nutritional supplements which may interfere with the study evaluation in the last 3 months (e.g. Omega 3…)

In terms of associated pathology
19. Participant 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 participant in the study and/or may have an impact on the study assessments.
20. Participant 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).
21. Participant with recurrent porphyria, coronary insufficiency, ventricular rhythm disorders, severe hypertension, obstructive cardiomyopathy, hyperthyroidism.
22. Participant with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the participant to an undue risk.
23. Participant with known history of or suffering from autoimmune disease and/or immune deficiency.
24. Participant 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.
25. Participant with multiple allergies, anaphylactic shock history, evolutive allergic pathologies.
26. Participant with history of allergy or hypersensitivity to one of the components of the tested device
27. Participant 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.
28. Participant predisposed to keloids or hypertrophic scarring.
29. Participant with coagulation and/or homeostasis disorders.

Relating to previous or ongoing treatment
30. Participant currently using or having used in the past month cosmetic products such as cosmetic antipigmentation creams or products (for example cream with ascorbic acid).
31. Participant 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 and during the study.
32. Participant receiving any treatment that, in the opinion of the investigator, may interfere with test results or put the participant to undue risk.
33. Participant 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 3 days. immunosuppressors and/or corticoids during the 4 previous weeks and during the study;
• retinoids during the 6 previous months and during the study.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

Suisselle

Study start

Feb 1, 2027 Estimated

Primary completion

Aug 31, 2027 Estimated

Study completion

Aug 31, 2027 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts