A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Tech… (NCT06000839) | Clinical Trial Compass
CompletedNot Applicable
A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)
France41 participantsStarted 2022-10-07
Plain-language summary
The current post-market clinical investigation has been designed to evaluate the efficacy and safety of CELLBOOSTER® Lift, a HA-based product marketed by SUISSELLE SA. For this purpose, healthy subjects with signs of skin aging with mild to moderate wrinkles, skin laxity, dry and dull skin on the face, received a 3-session treatment and were followed-up over a 4-month period after the initial injection.
Several objective measurements of skin quality were performed with different parameters: skin elasticity, density, dryness, microcirculation, wrinkles, color/homogeneity. Clinical improvement was also evaluated, as well as subject and investigator satisfactions.
The safety of the injections was also followed with injection site reactions and adverse events collection.
Who can participate
Age range35 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Caucasian
* Phototype II to III
* Subject with signs of cutaneous ageing on the face with mild to moderate wrinkles, skin laxity, dry and dull skin on face.
* Subject with a skin hydration rate on cheekbones \< 60 UA, measured with Corneometer®.
* Subject looking for an 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 with 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:
* Pregnant or nursing woman or planning a pregnancy during the study.
* Woman menopaused from less than 1 year or in perimenopause, without hormonal treatment.
* 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 4.500 euros as compensations for th…
What they're measuring
1
Change from baseline of epidermis hydration higher than 2 AU