Effectiveness and Safety of Cellbooster Shape in Healthy Subjects
ConditionSkin Aging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorSuisselle
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy subject.
Sex: male and female.
Phototype II to IV.
Age: from 35 years old.
Disqualifiers
Pregnant or nursing woman or planning a pregnancy during the study.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Skin booster injection (CBS)
DeviceThree 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).
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Experimental: CellBooster® Shape facial injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion 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 42Secondary outcomes
1
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 702
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 703
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 284
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 Source ClinicalTrials.gov