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EstheticsRF-HA-FB-2024NCT06915402

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

A study testing "LMW - CL - HA FACE/BODY in people with Esthetics, run by Rose Pharma SA at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esthetics
What is being tested?
"LMW - CL - HA FACE/BODY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSwitzerland
Study dates
24 Jun 2025to 13 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • EOC- Ospedale Regionale di Lugano

    Viganello

Other trials in Switzerland

About this study

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

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
Being tested
"LMW - CL - HA FACE/BODY

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "LMW - CL - HA FACE/BODYDevice

    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.

Study groups in NCT06915402
Study groupRoleWhat they receive
Open Non-comparativeExperimentalLMW - 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.
Receives: Device: "LMW - CL - HA FACE/BODY

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  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 during all the study visits by Facial Volume Loss Scale

    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 (including the cheek, temple, preauricular, and periorbital areas); no prominent bony landmarks; no visibility of underlying musculature. Grade 2: An intermediate point between Grade 1 and Grade 3. Grade 3: Moderate concavity of one or more facial regions (including the cheek, temple, preauricular, and periorbital areas); prominence of bony landmarks; may have visibility of underlying musculature. Grade 4: An intermediate point between Grade 3 and Grade 5. Grade 5: Severe indentation of one or more facial regions (including the cheek, temple, preauricular, and periorbital areas); severe prominence of bony landmarks; clear visibility of underlying musculature.

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

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

    the Global Aesthetic Improvement Scale (GAIS) scale will be assessed. The GAIS will be completed independently by both the Subject and the physician. The GAIS is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories were "worse," "no change," "improved," "much improved," and "very much improved."

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

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

    A Numerical Rating Scale (NRS) will be administered to the Subject at V0. The numeric rating scale is a scale designed to help assess the extent of an individual's pain and improve communication regarding pain with health care providers. This scale can help guide the diagnostic process, track the progression of the pain, and more. Numeric pain rating scale, which measures 0-10 - with 0 as no pain and 10 as the worst pain imaginable.

    Measured: V0 (Baseline visit day 0, IP administration)

  4. To evaluate Subject satisfaction after 6 months from baseline.

    To evaluate Subject satisfaction after 6 months from baseline, a 5 Likert Scale will be completed by the Subject at EOS visit (V3). The Likert scale is a five point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. Here's a breakdown of a typical 5-point Likert scale:

    1. Strongly Disagree
    2. Disagree
    3. Neutral (or Neither Agree nor Disagree)
    4. Agree
    5. Strongly Agree This scale allows respondents to express the intensity of their feelings towards a given statement, making it easier to quantify subjective data. It's widely used because it's simple to understand and analyze.

    Measured: V3 (6 months from V0)

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

    Facial examination (e.g., reddening, oedema, itching and pain in the touch, bruising, hardening or nodules at the injection site, coloring and discoloring of the skin at the point of injection) will be assessed at each visit

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start24 Jun 2025
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915402
Sponsor's protocol ID
RF-HA-FB-2024
Acronym
RF-HA-FB-2024
Status last verified
May 2026
First submitted
27 Mar 2025
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing "LMW - CL - HA FACE/BODY in people with Esthetics, run by Rose Pharma SA at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: V0 (Screening/Base line (V0) and V3 (End of Study) 6 months from V0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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