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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: "LMW - CL - HA FACE/BODY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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).
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)
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)
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:
- Strongly Disagree
- Disagree
- Neutral (or Neither Agree nor Disagree)
- Agree
- 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)
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.
- First posted8 Apr 2025
- Study start24 Jun 2025
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EstheticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rose Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corrado Parodi, Dr. med., Principal investigator, Ospedale Regionale di Lugano- Servizio di Chirurgia Plastica, Ricostruttiva ed Estetica EOC Ospedale Regionale di Lugano Via Pietro Capelli 1 CH-6962 Vi-ganello
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06915402
- Acronym / sponsor ID
- RF-HA-FB-2024 / RF-HA-FB-2024
- Conditions
- Esthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rose Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Non-comparative | Experimental | Device: "LMW - CL - HA FACE/BODYLMW - 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "LMW - CL - HA FACE/BODYThe 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. | Device | Open Non-comparative |
Primary outcome
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
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.
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: V0 (Baseline visit day 0, IP administration)
To evaluate Subject satisfaction after 6 months from baseline.
Time frame: V3 (6 months from V0)
To evaluate the safety and tolerability of LMW - CL - HA FACE/BODY
Time frame: V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) V2 (3 months from V0) V3 (6 months from V0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrado Parodi, Dr. med. principal investigator
Ospedale Regionale di Lugano- Servizio di Chirurgia Plastica, Ricostruttiva ed Estetica EOC Ospedale Regionale di Lugano Via Pietro Capelli 1 CH-6962 Vi-ganello
1 site in 1 country: see every site and its status.
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.