Volume Deficiency in the Mid-FaceFaceHyalNCT05747456
Study of a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face (FaceHyal)
A study testing IPN-21-SENSE in people with Volume Deficiency in the Mid-Face and Aging, run by Laboratoires Vivacy at 1 site in France.
Trial summary
The primary objective of the study is to demonstrate the superiority of IPN-21-SENSE 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 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Volume Deficiency in the Mid-Face, Aging, Aesthetics
- What is being tested?
- IPN-21-SENSE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2023to 2 Sep 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 30 and 84 years.
- Seeking correction of the mid-face volume deficit, and agrees with the recommendation of 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.
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 Mid-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 35Show fewer
- Subject having received 4,500 Euros in indemnities for participation in research involving human beings in France in the past 12 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 eligible if asymptomatic at time of inclusion.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Subject with any history of healing disorders.
- Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to lidocaine, or to antiseptic solution or any other amide type local anaesthetics.
- Subject presenting a history of severe, evolutive, unstable, or recent allergies.
- Subject suffering from porphyria.
- Subject with a cancer in areas close to the injection site, and subjects with a melanoma
- Subject with epilepsy or severe respiratory or cardiac function disorder.
- Subject with severe renal or hepatic functions disorders.
- Relating to previous or ongoing treatment:
- Subject having received treatment with a laser or ultrasound, a dermabrasion, a surgery, a deep chemical 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, defined as the zygomaticomalar and the anteromedial cheek regions, within the past 18 months prior to inclusion.
- Subject having received injection with a resorbable filling product in the nasolabial folds and/or the eye shadows, within the past 12 months prior to inclusion.
- Subject having received injection with a resorbable filling product in any part of the body of more than 8 mL within the past 12 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, or a surgery in the mid-face, or who plan to undergo any of these procedures during the study.
- Subject under medications which may cause lipo-atrophy.
- Subject using medication that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc)
- Subject being under immunosuppressive therapy.
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- Antihistamines during the 3 days 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.
- Subject having received a covid vaccine less than 4 weeks before the IPN-21-SENSE injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study of IPN-21-SENSE, a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face
The primary objective of the study is to demonstrate the superiority of IPN-21-SENSE 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 prospective, randomized, no-treatment controlled clinical trial of a proposed class III medical device. This study is designed to demonstrate clinical safety and performance of the IPN-21-SENSE dermal filler in the restoration or creation of volume in the mid-face.
The objective of this study is to demonstrate the superiority of IPN-21-SENSE 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 IPN-21-SENSE 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 two study centers in France and Poland.
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 IPN-21-SENSE at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with IPN-21-SENSE at 24 weeks after baseline).
The total duration of subject participation ranges from 18 months (treatment group) to 24 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30 months.
- Conditions
- Volume Deficiency in the Mid-Face, Aging, Aesthetics
- Being tested
- IPN-21-SENSE
- 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.
IPN-21-SENSEDevice
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.
IPN-21-SENSEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IPN-21-SENSE Treatment Group | Experimental | Subjects randomized (5:1 ratio) to receive an initial treatment with IPN-21-SENSE 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. Receives: Device: IPN-21-SENSE |
| No-Treatment Control Group, then Delayed Treatment with IPN-21-SENSE | Other | No-Treatment for the first 6-month, then subjects will receive a delayed treatment with IPN-21-SENSE 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. Receives: Device: IPN-21-SENSE |
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:
- 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.
- 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:
- 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.
- 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 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.
- First posted28 Feb 2023
- Study start22 Feb 2023
- Primary completion30 Apr 2024
- Study completion2 Sep 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
- Prospective, Randomized, No-Treatment Controlled Trial. Subjects will be randomized (5:1 ratio) to the IPN-21-SENSE (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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia MOREL-MANDRINO, MD, Principal investigator, Eurofins Dermscan, Villeurbanne, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747456
- Sponsor's protocol ID
- VIV-IPN-21-SENSE-01
- Acronym
- FaceHyal
- Status last verified
- Sep 2025
- First submitted
- 17 Feb 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 IPN-21-SENSE, a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face
- ClinicalTrials.gov ID
- NCT05747456
- Acronym / sponsor ID
- FaceHyal / VIV-IPN-21-SENSE-01
- Conditions
- Volume Deficiency in the Mid-Face, Aging, Aesthetics
- Keywords
- Mid-Face, Hyaluronic Acid, Volume, Aging, Aesthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 28 Feb 2023 (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 IPN-21-SENSE versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
Detailed description
This is a prospective, randomized, no-treatment controlled clinical trial of a proposed class III medical device. This study is designed to demonstrate clinical safety and performance of the IPN-21-SENSE dermal filler in the restoration or creation of volume in the mid-face.
The objective of this study is to demonstrate the superiority of IPN-21-SENSE 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 IPN-21-SENSE 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 two study centers in France and Poland.
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 IPN-21-SENSE at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with IPN-21-SENSE at 24 weeks after baseline).
The total duration of subject participation ranges from 18 months (treatment group) to 24 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomized, No-Treatment Controlled Trial. Subjects will be randomized (5:1 ratio) to the IPN-21-SENSE (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 |
|---|---|---|
| IPN-21-SENSE Treatment Group | Experimental | Device: IPN-21-SENSESubjects randomized (5:1 ratio) to receive an initial treatment with IPN-21-SENSE 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. |
| No-Treatment Control Group, then Delayed Treatment with IPN-21-SENSE | Other | Device: IPN-21-SENSENo-Treatment for the first 6-month, then subjects will receive a delayed treatment with IPN-21-SENSE 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. |
Who may qualify
- Ages
- 30 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 30 and 84 years.
- Seeking correction of the mid-face volume deficit, and agrees with the recommendation of 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 (35 listed)
- Pregnant or breastfeeding woman, or planning a pregnancy during the study.
- Scars, moles, tattoo, or anything on the Mid-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 |
|---|---|---|
| IPN-21-SENSEUp 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. | Device | IPN-21-SENSE Treatment Group |
| IPN-21-SENSEUp 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. | Device | No-Treatment Control Group, then Delayed Treatment with IPN-21-SENSE |
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 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
Dermal Fillers, Cheek Augmentation
Not yet recruiting
Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
Laxity; Skin, Volume Deficiency in the Mid-Face
Recruiting
A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Volume Deficiency in the Mid-Face, Skin Laxity
Active, not recruiting
Clinical Investigation Evaluating the Safety and Feasibility of Adipearl
Mid-face Volume Deficiency
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.
Patricia MOREL-MANDRINO, MD principal investigator
Eurofins Dermscan, Villeurbanne, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPN-21-SENSE 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 35 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?
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.