Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks

NCT06915402 | Not Yet Recruiting

• 1 other identifier: RF-HA-FB-2024
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Midface volume loss is a typical sign of facial aging. Age-related loss of subcutaneous fullness in the malar prominence results in a less healthy facial proportion. Indeed, the primary goal in any rejuvenation procedure should be to restore the balanced distribution of facial fullness that characterizes the youthful face. Rejuvenating treatments of the cheeks have a significant effect on an overall appearance and on neighbouring periorbital area, making additional treatments unnecessary. Innovative techniques to restore volume loss in the cheeks include the use of hyaluronic acid (HA) volumizing fillers created for facial sculpting. The result of such treatments is a harmonic and natural look, because the technique respects the physiologic alterations occurring during aging. HA is a natural and unbranched polymer belonging to a group of heteropolysaccharides named glycosaminoglycans. The primary structure of HA is a linear chain containing repeating disaccharide units linked by beta 1,4-glycosidic bonds. Each disaccharide consists of N-acetyl-d-glucosamine and d-glucuronic acid connected by beta-1,3-glycosidic bonds. HA is distributed ubiquitously throughout the extracellular matrix (ECM) of the skin. HA retains water to a remarkable extent; it is responsible for the hydration and viscoelasticity of the skin. As the skin ages, the content of ECM components, such as HA, decreases and this decrease directly correlates with volume loss, reduced moisture and increased rhytid formation. HA has excellent viscoelasticity, high moisture retention capacity, and unique hygroscopic properties. In addition to its properties, HA is well-tolerated, nonimmunogenic, biocompatible, and biodegradable. For these reasons it has been widely used in a variety of biomedical applications, including aesthetic medicine. HA-based formulations are normally injected into the dermis (as dermal fillers) to restore skin volume and minimize the appearance of wrinkles and folds. An ideal soft tissue filler should also provide an optimal balance of longevity, lifting capacity and ease of injection. In this context, "LMW - CL - HA FACE/BODY" is an injectable medical device indicated for the restoration of the physiological volumes of the face and body. The main ingredient is cross-linked HA of non-animal origin, produced by bacterial fermentation at low molecular weight (100KDa). The aim of this post-market, interventional, confirmative clinical investigation is to evaluate the performance and the safety of "LMW - CL - HA FACE/BODY" used as intended for the restoration of the physiological volumes of the cheeks

Conditions

Esthetics

Outcome Measures

Primary Outcomes (1)

• To evaluate the performance of the filler LMW - CL - HA FACE/BODY used as intended for the restoration of the physiological volumes of the cheeks after 6 months compared to baseline volume. Change will be assessed.

  To evaluate the performance of the filler LMW - CL - HA FACE/BODY used as intended for the restoration of the physiological volumes of the cheeks in patients requiring cheeks augmentation. The change from baseline will be assessed by the physician and Facial Volume Loss Scale (FVLS) will be used at the end of the study (V3). For evaluation of FVLS photographs will be taken using a 2D camera according to standardized and reproducible procedures. The FVLS includes five gradations. The face is assessed according to three criteria: contour, bony prominence, and visibility of musculature. Scale grades are: Grade 1. Mild flattening or shadowing of one or more facial regions; Grade 2: An intermediate point between Grade 1 and Grade 3. Grade 3: Moderate concavity of one or more facial regions. Grade 4: An intermediate point between Grade 3 and Grade 5. Grade 5: Severe indentation of one or more facial regions.

  V0 (Screening/Base line (V0) and V3 (End of Study) 6 months from V0

Secondary Outcomes (5)

• To evaluate the performance of the filler LMW - CL - HA FACE/BODY used as intended for the restoration of the physiological volumes of the cheeks during all the study visits by Facial Volume Loss Scale

  V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0).

• To evaluate the performance of the filler LMW - CL - HA FACE/BODY to improve aesthetic appearance by GAIS at baseline and follow-up visits

  V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0)

• To evaluate pain intensity after injection of LMW - CL - HA FACE/BODY

  V0 (Baseline visit day 0, IP administration)

• To evaluate Subject satisfaction after 6 months from baseline.

  V3 (6 months from V0)

• To evaluate the safety and tolerability of LMW - CL - HA FACE/BODY

  V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0)

Other Outcomes (2)

• Assessment of Device Deficiency/Incidents.

  V0 (Baseline visit day 0, IP administration) V1 (15 days from V0)

• Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.

  V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0)

Study Arms (1)

Open Non-comparative

EXPERIMENTAL

LMW - CL -HA FACE/BODY is used as intended for the restoration of the physiological volumes of the cheeks. In this study, it is planned to include 26 areas (1 area comprises both cheeks), including a drop-out rate of 10%. "LMW - CL - HA FACE/BODY" is available in a double pack containing two 2 ml syringes and for this study the package containing two 2 ml syringes will be used.

Device: "LMW - CL - HA FACE/BODY

Interventions

"LMW - CL - HA FACE/BODY DEVICE

The dosage to be used for the individual case is at the discretion of the doctor. The periodicity with which to repeat the procedure depends on different factors, concerning both the physiology of the patient (skin type, individual metabolism, anatomy, age) and lifestyle; another element to consider is related to the implantation techniques adopted. After the first treatment, the result can be retouched after 15 days, repeating the treatment after 9-12 months to maintain the results obtained. Local anesthesia for facial treatments can be performed, in order to ensure the necessary comfort for the patient. The area of intervention must be cleaned with antiseptic solutions before proceeding to the implant. Do not use quaternary ammonium-based disinfectants, as they can react with the HA and form precipitates."LMW - CL - HA FACE/BODY" is to be used intracutaneously and must not be injected into the blood vessels. Further details on the injection procedure are reported in the IFU.

Open Non-comparative

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject Informed consent form (ICF) signed;
• Female and male Subjects aged 18-75 years;
• Subjects with low moderate and moderate kind of skin sagging of the face (FVLS between 2 and 4 score) desiring augmentation of both cheeks;
• Willingness to follow all study procedures, including attending all site visits, tests and examinations;
• Agreeing to present at each study visit without make-up;
• Accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
• Willingness to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions or laser) or intense cold after the treatment and until the complete absorption of swelling and reddening.

Sponsors & Collaborators

• Rose Pharma SA: lead

Study Officials

• Corrado Parodi, Dr. med.

  Ospedale Regionale di Lugano- Servizio di Chirurgia Plastica, Ricostruttiva ed Estetica EOC Ospedale Regionale di Lugano Via Pietro Capelli 1 CH-6962 Vi-ganello

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrado Parodi, Dr. med.

CONTACT

091 811 77 30; Corrado.Parodi@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04