Volume Deficiency in the Mid-FaceMidFaceXXLNCT05355454

Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face

A study testing STYLAGE® XXL in people with Volume Deficiency in the Mid-Face and Aging, run by Laboratoires Vivacy at 1 site in France.

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

The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face. Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Volume Deficiency in the Mid-Face, Aging, Aesthetics
What is being tested?: STYLAGE® XXL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteFrance
Study dates: 6 Jun 2022to 25 Apr 2025
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 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged between 30 and 65 years
Seeking correction of his/her mid-face volume deficit, and agrees with recommendation by the Investigator
Accept the obligation not to receive any other facial procedures or treatments impacting facial volume augmentation at any time during the study
Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator
Psychologically able to understand the study related information and to give a written informed consent
Have voluntarily provided written informed consent to participate in the study, and use of data privacy (sign the ethics committee approved Informed Consent Form), prior to any study-related procedure being performed
Female of childbearing potential (sexually active, not sterile, nor postmenopausal for at least 1 year) must have a negative urine pregnancy test (UPT) at Visit 1 (or Visit 1b), and use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and for the duration of the study
Affiliated to a health social security system (for France only)

Who cannot join

In terms of population:
Pregnant or breastfeeding woman, or planning a pregnancy during the study
Scars, moles, tattoo, or anything on the face which might interfere with the evaluation
Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
Subject in a social or sanitary establishment
Subject participating to another research on human beings or who is in an exclusion period of one

Show all 27Show fewer

Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study (for France only)
In terms of associated pathology:
Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the investigator
Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results
Subject with known history of or suffering from autoimmune disease and/or immune deficiency
Subject suffering from active inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. herpes, acne). Subject with recurrent herpes in the Midface area is not eligible even if asymptomatic at time of inclusion
Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the components of the tested device
Subject with a history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localisation
Subject with a tendency to develop keloids or hypertrophic scars
Relating to previous or ongoing treatment:
Subject having received treatment with a laser, a dermabrasion, a surgery, a peeling, or other ablative procedure on the Midface area within the past 12 months prior to inclusion
Subject having received injection with a resorbable filling product in the Midface area within the past 18 months prior to inclusion
Subject having received at any time injection with a slowly resorbable filling product (e.g. polylactic acid, calcium hydroxyapatite, combinations of HA and Hypromellose) or with a non-resorbable filling product (e.g. polyacrylamide or silicone)
Subject having received at any time a treatment with tensor threads in the Midface area
Subject under medications which may cause lipo-atrophy
Subject using medication such as aspirin, NSAIDs (e.g. ibuprofen), antiplatelet agents, anticoagulants, vitamin C within one week prior to inclusion and not agreeing not to take such treatments within 1 week prior to visit 2 (M1) or being a chronic user of anticoagulant treatment
Subject undergoing a topical treatment on the test area or a systemic treatment:
Antihistamines during the 2 weeks prior to study start
Immunosuppressors and/or corticoids during the 4 weeks prior to study start
Retinoids during the 6 months prior to study start

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Medical Saint Jean
Arras

Other trials in France

About this study

Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study of STYLAGE® XXL Versus No-Treatment for Volume Deficiency in the Mid-face

The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Read the detailed description

This is a multicenter, prospective, randomized, no-treatment controlled post-market clinical follow-up of a class III medical device. This study is designed to evaluate the safety and effectiveness of STYLAGE® XXL in the restorationor creation of volume in the mid-face.

The objective of this study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system.

Effectiveness of STYLAGE® XXL will be demonstrated if the mean volumetric change at 24 weeks after baseline from pre-treatment in the treatment group is statistically superior to the mean change in the delayed treatment (control) group.

In total, approximately 90 subjects will be enrolled across three study centers in Switzerland, Austria, and France.

Subjects will be randomized to the treatment group or delayed treatment (control) group at a 5:1 ratio (i.e., there will be 5 more subjects treated with STYLAGE® XXL at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with STYLAGE® XXL at 24 weeks after baseline).

The total duration of subject participation ranges from 18-19 months (treatment group) to 24-25 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30-31 months.

Conditions: Volume Deficiency in the Mid-Face, Aging, Aesthetics
Being tested: STYLAGE® XXL
Keywords: Mid-Face, Hyaluronic Acid, Volume, Aging, Aesthetics

What participants receive

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

STYLAGE® XXLDevice
Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face.
Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face.
Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.
STYLAGE® XXLDevice
Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face.
Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face.
Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.

Study groups in NCT05355454
Study group	Role	What they receive
STYLAGE® XXL Treatment Group	Experimental	Subjects randomized (5:1 ratio) to receive an initial treatment with STYLAGE® XXL Crosslinked Hyaluronic Acid Gel up to 8mL, based on the PI's assessment, in combination with the aesthetic goal of the subject, then an optional touch-up treatment session 4 weeks later, up to 4mL. Subjects will also be offered an optional retreatment at week 72 after initial treatment, up to 8mL. Receives: Device: STYLAGE® XXL
No-Treatment Control Group, then Delayed Treatment with STYLAGE® XXL	Other	No-Treatment for the first 6-month, then subjects will receive a delayed treatment with STYLAGE® XXL Crosslinked Hyaluronic Acid Gel up to 8mL, based on the PI's assessment, in combination with the aesthetic goal of the subject, then an optional touch-up treatment session 4 weeks later, up to 4mL. Subjects will also be offered an optional retreatment at week 72 after initial treatment, up to 8mL. Receives: Device: STYLAGE® XXL

What is being measured

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

Mid-Face Volumetric change
Mean volumetric change between the treatment group and no-treatment control group at 24 (V4) weeks after baseline (V1)
Measured: 24 weeks after baseline

Secondary outcomes (11)

Mid-Face Volumetric change
Mean volumetric change between the treatment group and no-treatment control group at 4 (V2) and 12 (V3) weeks after baseline (V1)
Measured: 4, and 12 weeks after baseline
Mid-Face Volumetric change
Mean volumetric change between pre-treatment and directly after treatment at V1 (or V1b), and 4 (V2/V2b), 12 (V3/V3b), 48 (V5), and 72 (V6) weeks after initial treatment, in both groups pooled.
Measured: 4, 12, 24, 48, and 72 weeks after initial treatment
Global Aesthetic Improvement, by the Subjects
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Subjects, between the treatment group and no-treatment control group.
GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Measured: 4, 12, and 24 weeks after baseline
Global Aesthetic Improvement, by the Subjects
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Subjects, in both groups pooled.
GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Measured: 4, 12, 24, 48, and 72 weeks after initial treatment
Global Aesthetic Improvement, by the Investigators
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Investigators, between the treatment group and no-treatment control group.
GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Measured: 4, 12, and 24 weeks after baseline
Global Aesthetic Improvement, by the Investigators
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Investigators, in both groups pooled.
GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Measured: 4, 12, 24, 48, and 72 weeks after initial treatment
FACE-Q, by the Subjects
Rash-transformed score of the FACE-Q, assessed by the Subjects, between the treatment group and no-treatment control group.
FACE-Q is a patient-reported outcome (PRO) measure that can be used to measure outcomes of aesthetic facial procedures and products from the patient's perspective, composed of a set of independently functioning scales/checklists. In this study; two scales are assessed:
1. FACE-Q - Satisfaction with cheekbones: This questionnaire consists of 10 items, and measures the appearance of cheekbones with items that ask about shape, contour and symmetry, as well as how attractive, high and well-defined the cheekbones look.
2. FACE-Q - Satisfaction with outcome. This questionnaire consists of 6 items, and measures satisfaction with the result of a facial procedure, e.g., pleased with the result, result is fantastic.
The total score is converted to a score from 0 to 100, with higher scores reflect a better outcome.
Measured: Baseline, and 4, 12, and 24 weeks after baseline
FACE-Q, by the Subjects
Rash-transformed score of the FACE-Q, assessed by the Subjects, in both groups pooled.
FACE-Q is a patient-reported outcome (PRO) measure that can be used to measure outcomes of aesthetic facial procedures and products from the patient's perspective, composed of a set of independently functioning scales/checklists. In this study; two scales are assessed:
1. FACE-Q - Satisfaction with cheekbones: This questionnaire consists of 10 items, and measures the appearance of cheekbones with items that ask about shape, contour and symmetry, as well as how attractive, high and well-defined the cheekbones look.
2. FACE-Q - Satisfaction with outcome. This questionnaire consists of 6 items, and measures satisfaction with the result of a facial procedure, e.g., pleased with the result, result is fantastic.
The total score is converted to a score from 0 to 100, with higher scores reflect a better outcome.
Measured: Initial treatment, and 4, 12, 24, 48, and 72 weeks after initial treatment
Wrinkle Severity Rating Scale (WSRS), by the Investigators.
Nasolabial Fold Severity using the wrinkle severity rating scale (WSRS), assessed by the Investigators, between the treatment group and no-treatment control group.
The WSRS (Wrinkle Severity Rating Scale) is a 5-point rating scale to determine the severity of the nasolabial folds (NLF), with lower scores mean better condition (less severity), with 1 means "Absent - No visible NLF, continuous skin line" and 5 means "Extreme - Extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched".
Measured: 4, 12, and 24 weeks after baseline
Wrinkle Severity Rating Scale (WSRS), by the Investigators.
Nasolabial Fold Severity using the wrinkle severity rating scale (WSRS), assessed by the Investigators, in both groups pooled.
The WSRS (Wrinkle Severity Rating Scale) is a 5-point rating scale to determine the severity of the nasolabial folds (NLF), with lower scores mean better condition (less severity), with 1 means "Absent - No visible NLF, continuous skin line" and 5 means "Extreme - Extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched".
Measured: 4, 12, 24, 48, and 72 weeks after initial treatment
Ease of sculpting and massaging, by the Investigators
Ease of sculpting and massaging of the HA gel, assessed by the investigator after each treatment session, on a 5-point scale ranging from "Very easy" to "Very difficult", in both groups pooled.
Measured: Initial treatment, and 4, and 72 weeks after initial treatment

Timeline

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

6 Jun 202225 Apr 2025

First posted2 May 2022
Study start6 Jun 2022
Primary completion15 May 2024
Study completion25 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Volume Deficiency in the Mid-FaceStudies 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: Randomised
Intervention model: Parallel groups
Model description: Multi-Center, Prospective, Randomized, No-Treatment Controlled Trial. Subjects will be randomized (5:1 ratio) to the STYLAGE® XXL (treatment) arm or the no-treatment control arm. After 24 weeks, the no-treatment control arm (delayed treatment group) will receive their first treatment and will then follow the same schedule as the initial treatment group. After the no-treatment control group receives treatment, data from both groups will be pooled.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05355454
Sponsor's protocol ID: VIV-STYL-XXL-02
Acronym: MidFaceXXL
Status last verified: Sep 2025
First submitted: 25 Apr 2022
Last updated: 10 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
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All Volume Deficiency in the Mid-Face trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study of STYLAGE® XXL Versus No-Treatment for Volume Deficiency in the Mid-face
ClinicalTrials.gov ID: NCT05355454
Acronym / sponsor ID: MidFaceXXL / VIV-STYL-XXL-02
Conditions: Volume Deficiency in the Mid-Face, Aging, Aesthetics
Keywords: Mid-Face, Hyaluronic Acid, Volume, Aging, Aesthetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Laboratoires VivacyIndustry (pharma, biotech, devices)
Collaborators: Avania, Canfield Scientific Inc.
Study start: 6 Jun 2022 (actual)
Primary completion: 15 May 2024 (actual)
Study completion: 25 Apr 2025 (actual)
First posted: 2 May 2022 (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.

The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Detailed description

The objective of this study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system.

In total, approximately 90 subjects will be enrolled across three study centers in Switzerland, Austria, and France.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Multi-Center, Prospective, Randomized, No-Treatment Controlled Trial. Subjects will be randomized (5:1 ratio) to the STYLAGE® XXL (treatment) arm or the no-treatment control arm. After 24 weeks, the no-treatment control arm (delayed treatment group) will receive their first treatment and will then follow the same schedule as the initial treatment group. After the no-treatment control group receives treatment, data from both groups will be pooled.

Arm	Type	Receives
STYLAGE® XXL Treatment Group	Experimental	Device: STYLAGE® XXLSubjects randomized (5:1 ratio) to receive an initial treatment with STYLAGE® XXL Crosslinked Hyaluronic Acid Gel up to 8mL, based on the PI's assessment, in combination with the aesthetic goal of the subject, then an optional touch-up treatment session 4 weeks later, up to 4mL. Subjects will also be offered an optional retreatment at week 72 after initial treatment, up to 8mL.
No-Treatment Control Group, then Delayed Treatment with STYLAGE® XXL	Other	Device: STYLAGE® XXLNo-Treatment for the first 6-month, then subjects will receive a delayed treatment with STYLAGE® XXL Crosslinked Hyaluronic Acid Gel up to 8mL, based on the PI's assessment, in combination with the aesthetic goal of the subject, then an optional touch-up treatment session 4 weeks later, up to 4mL. Subjects will also be offered an optional retreatment at week 72 after initial treatment, up to 8mL.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Aged between 30 and 65 years
Seeking correction of his/her mid-face volume deficit, and agrees with recommendation by the Investigator
Accept the obligation not to receive any other facial procedures or treatments impacting facial volume augmentation at any time during the study
Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator
Psychologically able to understand the study related information and to give a written informed consent

Key exclusion criteria (27 listed)

Pregnant or breastfeeding woman, or planning a pregnancy during the study
Scars, moles, tattoo, or anything on the face which might interfere with the evaluation
Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
Subject in a social or sanitary establishment
Subject participating to another research on human beings or who is in an exclusion period of one

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
STYLAGE® XXLUp to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face. Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face. Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.	Device	STYLAGE® XXL Treatment Group
STYLAGE® XXLUp to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face. Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face. Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.	Device	No-Treatment Control Group, then Delayed Treatment with STYLAGE® XXL

Primary outcome

Mid-Face Volumetric change
Time frame: 24 weeks after baseline
Mean volumetric change between the treatment group and no-treatment control group at 24 (V4) weeks after baseline (V1)

11 secondary outcomes

Mid-Face Volumetric change
Time frame: 4, and 12 weeks after baseline
Mid-Face Volumetric change
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
Global Aesthetic Improvement, by the Subjects
Time frame: 4, 12, and 24 weeks after baseline
Global Aesthetic Improvement, by the Subjects
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
Global Aesthetic Improvement, by the Investigators
Time frame: 4, 12, and 24 weeks after baseline
Global Aesthetic Improvement, by the Investigators
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
FACE-Q, by the Subjects
Time frame: Baseline, and 4, 12, and 24 weeks after baseline
FACE-Q, by the Subjects
Time frame: Initial treatment, and 4, 12, 24, 48, and 72 weeks after initial treatment
Wrinkle Severity Rating Scale (WSRS), by the Investigators.
Time frame: 4, 12, and 24 weeks after baseline
Wrinkle Severity Rating Scale (WSRS), by the Investigators.
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
Ease of sculpting and massaging, by the Investigators
Time frame: Initial treatment, and 4, and 72 weeks after initial treatment

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 10 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Volume Deficiency in the Mid-Face

Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
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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.

Hervé RASPALDO, MD principal investigator

Private Clinic, GENEVA, SWITZERLAND

Hugues CARTIER, MD principal investigator

Centre Medical Saint-Jean, ARRAS, FRANCE

Thomas RAPPL, MD principal investigator

Medical Aesthetic Research Academy, GRAZ, AUSTRIA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing STYLAGE® XXL in people with Volume Deficiency in the Mid-Face and Aging, run by Laboratoires Vivacy at 1 site in France.

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 8 inclusion and 27 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 10 Sep 2025. 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 France. 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?

Mid-Face Volumetric change (time frame: 24 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05355454.

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 10 Sep 2025.