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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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).
Eurofins Dermscan Pharmascan
Villeurbanne, France
RECRUITINGProportion 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.
Time frame: Day 42
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.
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).
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.
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).
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.
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.
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".
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.
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).
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
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