Clinical trial NCT06915402: Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks
Official title: A Post-market, Interventional, Confirmative Clinical Investigation 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esthetics
Lead sponsor: Rose Pharma SA
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Subject Informed consent form (ICF) signed;
2. Female and male Subjects aged 18-75 years;
3. Subjects with low moderate and moderate kind of skin sagging of the face (FVLS between 2 and 4 score) desiring augmentation of both cheeks;
4. Willingness to follow all study procedures, including attending all site visits, tests and examinations;
5. Agreeing to present at each study visit without make-up;
6. Accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
7. 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.

Exclusion Criteria:

Subjects with asymmetries in the cheeks, which in the opinion of the PI could require treatment of only one side of the face, prior to study inclusion; 2. Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy); 3. Botulinum toxin injections in face areas other than forehead, lips, chin within 6 months prior to study inclusion; 4. Infectious or inflammatory processes near the area of intervention or in the face in general; 5. Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes; 6. Presence of tendon, bone or muscular implants near the area of intervention; 7. Presence of hypertrophic scars near the area of treatment; 8. Presence of permanent filler, of traction wires or prostheses in the face; 9. Ongoing cutaneous allergies; 10. Known hypersensitivity to cheloids; 11. Allergy or contraindications to device components; 12. Immune system illnesses/disease; 13. Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder); 14. Problems with coagulation or anti-coagulating therapies in progress; 15. Treatment with substances which act on blood fluidity (e.g. Aspirin, NSAIDs, Vitamin E) within 5 days prior to study inclusion; based on Investigator's judgment cardioaspirin might be allowed; 16. Known drug and/or alcohol abuse; 17. Mental incapacity that precludes adequate understanding or cooperation; 18. Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, chemical peeling, fillers) of the face within 6 months prior to study inclusion; 19. Pregnancy or breastfeeding; 20. Dental pathologies: tooth decay, abscesses, preparation for implants; 21. Participation in another investigational study within 1 month prior to study inclusion.

Primary outcomes:
measure: 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.
timeFrame: V0 (Screening/Base line (V0) and V3 (End of Study) 6 months from V0
Secondary outcomes:
measure: 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
timeFrame: V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0).
measure: To evaluate the performance of the filler LMW - CL - HA FACE/BODY to improve aesthetic appearance by GAIS at baseline and follow-up visits
timeFrame: V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0)
measure: To evaluate pain intensity after injection of LMW - CL - HA FACE/BODY
timeFrame: V0 (Baseline visit day 0, IP administration)
measure: To evaluate Subject satisfaction after 6 months from baseline.
timeFrame: V3 (6 months from V0)
measure: To evaluate the safety and tolerability of LMW - CL - HA FACE/BODY
timeFrame: V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0)
Other outcomes:
measure: Assessment of Device Deficiency/Incidents.
timeFrame: V0 (Baseline visit day 0, IP administration) V1 (15 days from V0)
measure: Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.
timeFrame: V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0)
Locations:
Study officials:
affiliation: Ospedale Regionale di Lugano- Servizio di Chirurgia Plastica, Ricostruttiva ed Estetica EOC Ospedale Regionale di Lugano Via Pietro Capelli 1 CH-6962 Vi-ganello
name: Corrado Parodi, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: