AgingAF3NCT04645576
Evaluation of the Efficacy and Safety of an Injectable Hyaluronic Acid-based Filler, Art Filler® Volume: Comparative Single-blind Study of the Non-inferiority Versus Juvéderm® Voluma on the Midface, Temple and Jaw-line and Non-comparative Study on the Chin. (AF3)
A study testing Face correction with injectable fillers in people with Aging, run by Laboratoires FILLMED at 1 site in France.
Trial summary
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Face correction with injectable fillers
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2019to 25 Jan 2021
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who had signed a written informed consent
- Man or Woman with an age ≥ 19 years old
- Subject having a Fitzpatrick Phototype I to IV (annex 6)
- Subject having a score of ≥ 2 in Global aesthetic 6-point scale scoring system on at least one area of interest (chin, midface, temples or jaw lines) (annex 1.1)
- Subject having at least one of the following scales by clinical scoring (annex 1.2/1.3/1.4/1.5)
- a grade of 2 or 3 on the ACRS Scale
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- a grade of 2 or 3 score on the MMVS Scale
- a grade of 2 or 3 or 4 score on ATHS Scale
- a grade of 2 or 3 score with NCJLS Scale
- Subject registered with health insurance regimen
- Woman agreeing to take a pregnancy test
Who cannot join
- Subject currently participating in another clinical study related to pharmaceuticals or medical devices or being in exclusion period of another clinical study.
- Subject deprived of freedom by an administrative or legal decision
- Subject who have received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including his participation in this study).
- Subject who had facial injections/implants of any non-absorbable fillers in her/his whole life.
- Subject who had laser sessions for skin rejuvenation or a laser resurfacing during the 12 previous months or a surgical facelift during the 2 years before the study.
- Subject with a history of facial aesthetic injection (hyaluronic acid within the previous year, botulinum toxin within the last 6 months and long-term temporary injectable implants (semi-permanent implants) within the previous 2 years).
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- Subject with a skin-retaining device on the face (mesh, gold wire, liquid silicone or other particulate material).
- Subject who undergo a non-invasive rejuvenation method such as moderate to deep peeling, ultrasound, radiofrequency devices or lasers within the last 6 months.
- Subject with a history of severe multiple allergies or anaphylactic shock.
- Subject with a known hypersensitivity to hyaluronic acid, Lidocaine and/or other components of Art Filler® Volume and Juvéderm Voluma solutions.
- Subject with a known hypersensitivity to chlorhexidine.
- Subject with a known hypersensitivity to lidocaine or local amide anesthetics.
- Subject tending to develop inflammatory skin diseases or hypertrophic scars.
- Subject with a history of streptococcal disease (recurring angina, rheumatic fever).
- Subject with oral or injectable corticoid treatment (or not stopped for at least 3 months). Inhaled corticoids are permitted as well as topical corticotherapy not involving the head or the neck.
- Subjects with any concomitant treatment (or not stopped for at least a year) by immunosuppressant or chemotherapy.
- Subject with a history of radiotherapy involving the head and the neck within the previous year.
- Subject with a history or a disease associated to the autoimmune or connective tissue disease.
- Subject presenting at his/her face and/or neck any skin disease, or an acute inflammatory reaction or a bacterial/viral infection or who had such an episode within the previous 6 weeks.
- Subject who took aspirin or anticoagulants at regular doses in the last 15 days prior to the act.
- Subject who has permanently been exposed to the sun or the UV during the last 15 days.
- Subject with dermatological condition or inflammation on or near the area to be treated (according to the opinion of the investigator).
- Pregnant or lactating woman.
- Subject with epilepsy not controlled by treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of an Injectable Hyaluronic Acid-based Filler, Art Filler® Volume: Comparative Single-blind Study of the Non-inferiority Versus Juvéderm® Voluma on the Midface, Temple and Jaw-line and Non-comparative Study on the Chin
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. A previous study has already shown the efficacy of Art Filler Volume on the midface, but this study was not comparative. It was thus interesting to compare the efficacy of Art Filler Volume to a reference product but also to test its efficacy on other areas including the temple, jaw-line and chin.
Read the detailed description
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. A previous study has already shown the efficacy of Art Filler Volume on the midface, but this study was not comparative. It was thus interesting to compare the efficacy of Art Filler Volume to a reference product but also to test its efficacy on other areas including the temple, jaw-line and chin.
In this context, it is proposed to conduct, in post-CE marking, a randomized, prospective and comparative study in order to document, an adequate aesthetic correction of the treated areas as well as their immediate and long-term tolerance. This study aims to document the filling capacity of Art Filler Volume, in relation to a product technically of the same order and considered as a reference2,3,4,5 (this study will be comparative on temple / midface and jawline but no on the chin were only Art Filler Volume will be injected). To do this, subjects in whom a correction of mid-facial areas and / or temple and / or jaw-lines and / or chin is sought, will be included. The aesthetic correction will be appreciated at 3 weeks. Subjects will be followed over 18 months. The persistence of the correction will be evaluated at 3, 6, 9, 12, 15 and 18 months.
No corrective injections with the products under study will be allowed. Each subject could be injected for maximum 2 different zones.
- Conditions
- Aging
- Being tested
- Face correction with injectable fillers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face correction with injectable fillersDevice
Injection of hyaluronic acid-based fillers
| Study group | Role | What they receive |
|---|---|---|
| Midface zone | Other | Injection in the mid-facial areas (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). Receives: Device: Face correction with injectable fillers |
| Temple | Other | Injection in the temples (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). Receives: Device: Face correction with injectable fillers |
| Jaw-line | Other | Injection in the jaw-line areas (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). Receives: Device: Face correction with injectable fillers |
| Chin | Experimental | The chin will only receive one injection of Art Filler Volume. Receives: Device: Face correction with injectable fillers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume correction on D21 with Art Filler Volume product
Objectively measure after a single injection of Art Filler® Volume the restoration of the chin volume versus a reference product, Juvéderm® Voluma, the restoration of midface, temple, and jaw-line from volumes baseline (D0) to D21 according to a global Aesthetic 6-point scale clinical scoring.
Measured: D21 (21 days after the injections)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start14 May 2019
- Primary completion2 Aug 2019
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- During the period of this clinical trial (18 months), only two products will be used for the aesthetic procedures (Art Filler Volume and Juvéderm Voluma). This prospective study will analyze 120 patients maximum who will receive dermal filler injections to the midface, temple, chin and jaw-line (cross-injection is authorized with maximum 2 zones per subject). The injections will be administered in a randomly assigned split-face design, except for the chin. One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). The chin will only receive one injection of Art Filler Volume.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires FILLMED
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferial FANIAN, MD, Study director, Laboratoires FILLMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645576
- Sponsor's protocol ID
- AF3:2018-A00287-48
- Other IDs
- 2018-A00287-48
- Acronym
- AF3
- Status last verified
- Mar 2022
- First submitted
- 20 Nov 2020
- Last updated
- 8 Mar 2022
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an Injectable Hyaluronic Acid-based Filler, Art Filler® Volume: Comparative Single-blind Study of the Non-inferiority Versus Juvéderm® Voluma on the Midface, Temple and Jaw-line and Non-comparative Study on the Chin
- ClinicalTrials.gov ID
- NCT04645576
- Acronym / sponsor ID
- AF3 / AF3:2018-A00287-48
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Laboratoires FILLMEDIndustry (pharma, biotech, devices)
- Study start
- 14 May 2019 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 27 Nov 2020 (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 function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. A previous study has already shown the efficacy of Art Filler Volume on the midface, but this study was not comparative. It was thus interesting to compare the efficacy of Art Filler Volume to a reference product but also to test its efficacy on other areas including the temple, jaw-line and chin.
Detailed description
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. A previous study has already shown the efficacy of Art Filler Volume on the midface, but this study was not comparative. It was thus interesting to compare the efficacy of Art Filler Volume to a reference product but also to test its efficacy on other areas including the temple, jaw-line and chin.
In this context, it is proposed to conduct, in post-CE marking, a randomized, prospective and comparative study in order to document, an adequate aesthetic correction of the treated areas as well as their immediate and long-term tolerance. This study aims to document the filling capacity of Art Filler Volume, in relation to a product technically of the same order and considered as a reference2,3,4,5 (this study will be comparative on temple / midface and jawline but no on the chin were only Art Filler Volume will be injected). To do this, subjects in whom a correction of mid-facial areas and / or temple and / or jaw-lines and / or chin is sought, will be included. The aesthetic correction will be appreciated at 3 weeks. Subjects will be followed over 18 months. The persistence of the correction will be evaluated at 3, 6, 9, 12, 15 and 18 months.
No corrective injections with the products under study will be allowed. Each subject could be injected for maximum 2 different zones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- During the period of this clinical trial (18 months), only two products will be used for the aesthetic procedures (Art Filler Volume and Juvéderm Voluma). This prospective study will analyze 120 patients maximum who will receive dermal filler injections to the midface, temple, chin and jaw-line (cross-injection is authorized with maximum 2 zones per subject). The injections will be administered in a randomly assigned split-face design, except for the chin. One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). The chin will only receive one injection of Art Filler Volume.
| Arm | Type | Receives |
|---|---|---|
| Midface zone | Other | Device: Face correction with injectable fillersInjection in the mid-facial areas (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). |
| Temple | Other | Device: Face correction with injectable fillersInjection in the temples (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). |
| Jaw-line | Other | Device: Face correction with injectable fillersInjection in the jaw-line areas (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). |
| Chin | Experimental | Device: Face correction with injectable fillersThe chin will only receive one injection of Art Filler Volume. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects who had signed a written informed consent
- Man or Woman with an age ≥ 19 years old
- Subject having a Fitzpatrick Phototype I to IV (annex 6)
- Subject having a score of ≥ 2 in Global aesthetic 6-point scale scoring system on at least one area of interest (chin, midface, temples or jaw lines) (annex 1.1)
- Subject having at least one of the following scales by clinical scoring (annex 1.2/1.3/1.4/1.5)
Key exclusion criteria (24 listed)
- Subject currently participating in another clinical study related to pharmaceuticals or medical devices or being in exclusion period of another clinical study.
- Subject deprived of freedom by an administrative or legal decision
- Subject who have received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including his participation in this study).
- Subject who had facial injections/implants of any non-absorbable fillers in her/his whole life.
- Subject who had laser sessions for skin rejuvenation or a laser resurfacing during the 12 previous months or a surgical facelift during the 2 years before the study.
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 |
|---|---|---|
| Face correction with injectable fillersInjection of hyaluronic acid-based fillers | Device | Chin, Jaw-line, Midface zone, Temple |
Primary outcome
Volume correction on D21 with Art Filler Volume product
Time frame: D21 (21 days after the injections)
Objectively measure after a single injection of Art Filler® Volume the restoration of the chin volume versus a reference product, Juvéderm® Voluma, the restoration of midface, temple, and jaw-line from volumes baseline (D0) to D21 according to a global Aesthetic 6-point scale clinical scoring.
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 8 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Ferial FANIAN, MD study director
Laboratoires FILLMED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face correction with injectable fillers in people with Aging, run by Laboratoires FILLMED 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 11 inclusion and 24 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 8 Mar 2022. 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?
Volume correction on D21 with Art Filler Volume product (time frame: D21 (21 days after the injections)). 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 8 Mar 2022.