Effectiveness and Safety of Cellbooster Glow in Healthy Subjects
Wrinkle Appearance · Skin Hydration in Healthy Volunteers · Skin Pigmentation · Skin Laxity · Dark Eye Circles (Periorbital Hyperpigmentation)
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 40 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 60 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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).
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
CellBooster® Glow facial injection
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).
CellBooster® Glow (CBG) Class III medical device
Composition:
- non-crosslinked Sodium Hyaluronate 18 mg
- amino acids (Cysteine, Glutathione, Glycine, Lysine, Proline, Valine)
- vitamins (Sodium Ascorbyl Phosphate, Biotin)
- phosphate buffer pH 6.8-7.6 q.s
Device: Injectable
Injectable DEVICE
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).
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change from baseline recorded at visit 1 (Day -7 to Day 0) of epidermis hydration measured with Corneometer® at Day 42.
Plazo: Day -7 to Day 0 and Day 42.
At each visit, five measurements will be taken on the right cheekbone, a few centimeters below the outer corner of the eye. The recorded value will be the average of the five measurements An improvement of epidermis hydration is defined as an increase higher than 2AU.
Medidas secundarias
Change from baseline of epidermis hydration measured with Corneometer® at Day 70.
Plazo: Day 70
No informado en este registro.
Proportion of participants having an improvement with CBG treatment as assessed by the investigator at Day 42 and Day 70, using the GAIS.
Plazo: Day 42 and Day 70
An improvement is defined as participant having a score "very much improved", "much improved" or "improved" on the GAIS
5-grade scale:
1. Very much improved
2. Much improved
3. Improved
4. No change
5. Worse
Degree of satisfaction of the injectors through the answers to a subjective evaluation questionnaire completed for each participant at Day 14.
Plazo: Day 14
For each question, the percentage of answers "satisfied" or "very satisfied" will be computed.
5-grade scale
1. :Strongly disagree
2. : Disagree
3. : Neither agree nor disagree
4. : Agree
5. : Strongly agree
Degree of satisfaction of the participants through the answers to a subjective evaluation questionnaire at Day 42 and Day 70.
Plazo: Day 42 and Day 70
For each question, the percentage of participant satisfied, (percentages of answers "agree" or "strongly agree") will be computed.
5-grade scale: Strongly disagree / Disagree / Neither agree nor disagree / Agree / Strongly agree
Change from baseline of skin elasticity measured with Cutometer® at Day 42 and Day 70.
Plazo: Day 42 and Day 70
No informado en este registro.
Change from baseline of skin microcirculation measured with Laser Doppler at Day 42 and Day 70
Plazo: Day 42 and Day 70
No informado en este registro.
Change from baseline of skin wrinkles measured with fringe projection system at Day 42 and Day 70.
Plazo: Day 42 and Day 70
No informado en este registro.
Change from baseline of skin roughness measured with fringe projection system at Day 42 and Day 70
Plazo: Day 42 and Day 70
No informado en este registro.
Illustration of the aesthetic effect with photos of the whole face (front face and profiles) with Colorface®.
Plazo: Day 0, Day 42 and Day 70
No informado en este registro.
Change from baseline in the skin color and homogeneity
Plazo: Day 0, Day 42 and Day 70
Change from baseline in the skin color and homogeneity (L\*, a\*, b\*, ITA°,IWA, H76) measured with Colorface® at Day 0, Day 42 and Day 70.
Change from baseline in the multi pigment spot measured with Colorface®
Plazo: Day 0, Day 42 and Day 70
Change from baseline in the multi pigment spot measured with Colorface® at Day 0, Day 42 and Day 70.
Change from baseline in the contrast dark circle/ surrounding skin measured with Colorface®
Plazo: Day 0, Day 42 and Day 70
Change from baseline in contrast dark circle/ surrounding skin in deltaL\*, deltaa\*, deltab\*, deltaE76) measured with Colorface® at Day 0, Day 42 and Day 70.
Change from baseline in the pigmented dark circle measured with Colorface®
Plazo: Day 0, Day 42 and Day 70
Change from baseline in the pigmented dark circle (L\*, a\*, b\*, H76) measured with Colorface® at Day 0, Day 42 and Day 70.
Change from baseline in the global redness inflammation (haemoglobin evaluation) measured with Colorface®
Plazo: Day 0, Day 42 and Day 70
No informado en este registro.
Change from baseline in gloss, and specular Gloss(GS)) measured with Colorface®
Plazo: Day 0, Day 42 and Day 70.
Change from baseline in gloss (contrast gloss (GC) and specular Gloss(GS)) measured with Colorface® at Day 0, Day 42 and Day 70.
Evaluation of Injection Site Reactions (ISRs) by the investigator on the face, immediately after each injection session (Day 0, Day 14 and Day 28) and at Day 42 and Day 70.
Plazo: Day 0, Day 14, Day 28, Day 42 and Day 70.
No informado en este registro.
Evaluation of Injection Site Reactions (ISRs) by the participant on the face during 2 weeks after each injection session.
Plazo: Day 0, Day 14, Day 28
Participant Injection Site Reactions (ISRs) will be tabulated by maximum severity, and duration, after each injection session.
Collection of adverse events (AEs) and concomitant treatments during the study.
Plazo: Day 0 to Day 70
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (2)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
2 centros
Eurofins Dermscan PharmascanAix-en-Provence, FranceEstado desconocido
Eurofins Dermscan PharmascanVilleurbanne, FranceEstado desconocido
Equipo y fechas
- Patrocinador principal
- Suisselle
- Inicio del estudio
- 1 feb 2027 Estimado
- Finalización primaria
- 31 ago 2027 Estimado
- Finalización del estudio
- 31 ago 2027 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Prospective, Open Study on the Safety and Effectiveness of CellBooster® Glow (Stabilized Hyaluronic Acid-based Complex) on Healthy Participants
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026