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NCT07929870
Effectiveness and Safety of Cellbooster Glow in Healthy Subjects
Conditions: Wrinkle Appearance, Skin Hydration in Healthy Volunteers, Skin Pigmentation, Skin Laxity, Dark Eye Circles (Periorbital Hyperpigmentation)
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Suisselle
Location: Eurofins Dermscan Pharmascan Aix-en-Provence
Summary
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).
Eligibility Criteria
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 (\
Source: ClinicalTrials.gov (NCT07929870). StuddyBuddy aggregates publicly available trial information.