Clinical investigation on a hyaluronic acid-based dermal filler used to restore cheek volume

Zusammenfassung der Studie

Loss of volume in the mid-facial area is a typical sign of facial aging. Age-related loss of subcutaneous fullness in the cheek prominence results in a facial proportion that appears less healthy. In fact, the primary goal of any rejuvenation procedure should be to restore the balanced distribution of facial fullness that characterizes a youthful face. Cheek rejuvenation treatments have a significant effect on overall appearance and the adjacent periorbital area, making further treatments unnecessary. Innovative techniques to restore lost cheek volume include the use of hyaluronic acid (HA) volumizing fillers designed to sculpt the face. The result of such treatments is a harmonious and natural appearance, as the technique respects the physiological changes that occur during aging. The aim of this confirmatory, interventional, and post-marketing clinical investigation is to evaluate the performance and safety of “LMW-CL-HA – FACE/BODY” used according to the intended indications for restoring physiological cheek volumes.

(BASEC)

Untersuchte Intervention

Each subject, after signing the informed consent form (ICF), will enter a screening phase during which baseline analyses will be conducted. The ICF must be signed before any procedure outlined in the study is performed. Four visits will be scheduled for each subject, during which various assessments will be conducted, as described in the flow chart. At V0, the investigator will collect data regarding demographic characteristics (e.g., gender, ethnicity, age), medical history (e.g., history of autoimmune disease, diabetes, etc.), and the subject's allergy history to medications. All eligibility criteria must be confirmed before enrolling the subject. At V0, enrolled subjects will be treated with “LMW-CL-HA – FACE/BODY” in the cheek areas following the instructions for use (IFU). A kit will be used for each subject. Performance will be evaluated by the investigator using the facial volume loss scale (FVLS) at each visit and the global aesthetic improvement scale (GAIS) from V0 until the end of the study (EOS/V3). The GAIS scale will also be completed by the subject. Photographs will be taken from V0 to V3 using a 2D camera. At V0, after the injection, the investigator will record the subject's pain intensity using the numerical rating scale (NRS). At V0, the enrolled subject will receive a diary to record any health issues and any concomitant medications taken during the study. A 5-point Likert scale will be used to assess the subject's satisfaction with the treatment at V3 and at the EOS visit (V3). Regarding safety, an assessment of possible skin reactions will be performed at each visit. Adverse events and concomitant medications will be monitored throughout the study duration. Device malfunctions will be monitored at each application of the investigational product (IP).

(BASEC)

Untersuchte Krankheit(en)

dermocosmetics

(BASEC)

Sponsor

Rose Pharma SA

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Tessin

(BASEC)

Datum der Bewilligung durch die Ethikkommission

25.03.2025

(BASEC)

Ergebnisse der Studie