Loss of Face VolumeAF4NCT04647513
Evaluation of the Efficacy and Safety of Three Injectable Hyaluronic Acid-based Fillers: Art Filler® Fine Lines, Art Filler® Universal and Art Filler® Lips
A study testing Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) in people with Loss of Face Volume, 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 and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loss of Face Volume
- What is being tested?
- Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2019to 21 Dec 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 aged ≥ 19 years old
- Subject having a Fitzpatrick Phototype I to IV
- Subject having a score of ≥ 1 in the Global aesthetic scale scoring system on at least one area of interest (forehead wrinkles, upper lip wrinkles, cheek folds, crow's feet wrinkles, nasolabial folds and/or marionette wrinkles) and/or ≤ 2 for the lip volume
- Subject having at least one of the following scales by clinical scoring
- For subjects injected by Art Filler Fine Lines:
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- a grade ≥ 3 and ≤ 6 on the upper lip wrinkles scale from Bazin
- a grade ≥ 3 and ≤ 5 on the cheek folds scale from Bazin
- For women :
- a grade ≥ 2 and ≤ 5 on the forehead wrinkles scale from Bazin
- a grade ≥ 2 and ≤ 6 on the crow's feet wrinkles scale from Bazin
- For men :
- a grade ≥ 2 and ≤ 6 on the forehead wrinkles from Bazin
- a grade ≥ 2 and ≤ 6 on the crow's feet wrinkles from Bazin
- For subjects injected by Art Filler Universal:
- a grade ≥ 0 and ≤ 2 on the lip volume fullness scale from Medicis (if the subject would like a soft effect on his/ her lips)
- For women, a grade ≥ 2 and ≤ 4 on the nasolabial folds scale from Bazin
- For men a grade ≥ 2 and ≤ 4 on the nasolabial folds scale from Bazin
- For subjects injected by Art Filler Lips:
- a grade ≥ 0 and ≤ 2 on the lip volume fullness scale from Medicis (if the subject would like a plumpled effect on his/ her lips)
- For women, a grade of 5 on the nasolabial folds scale from Bazin
- For men a grade ≥ 5 on the nasolabial folds scale from Bazin
- 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 has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including 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 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 underwent 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 Fine Lines®, Art Filler Universal® and Art Filler Fine Lips® 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 on his/her face 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 a general pathology, skin disease, dermatosis, acute or chronic systemic disease, and/or taking a general or topical treatment that in the opinion of the investigator may interfere with the treatment or compromise the subject's participation in the study
- Pregnant or lactating woman.
- Subject with epilepsy not controlled by treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies.
In this context, it is proposed to carry out in post-CE marking, an open, prospective and non-comparative study in order to document an adequate aesthetic correction of the most frequent areas treated with Art Filler Fine Lines, Art Filler Universal and Art Filler Lips as well as their immediate and long-term tolerance.
- Conditions
- Loss of Face Volume
- Being tested
- Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Device
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies.
| Study group | Role | What they receive |
|---|---|---|
| Art Filler Fine Lines (forehead) | Experimental | Injection of Art Filler Fine Lines in Forehead wrinkles Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
| Art Filler Fine Lines (upper lip) | Experimental | Injection of Art Filler Fine Lines in upper lip wrinkles Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
| Art Filler Fine Lines (cheek folds) | Experimental | Injection of Art Filler Fine Lines in cheek folds Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
| Art Filler Fine Lines (crow's feet) | Experimental | Injection of Art Filler Fine Lines in crow's feet Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
| Art Filler Universal (lips volume) | Experimental | Injection of Art Filler Universal in lips Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
| Art Filler Universal (nasolabial folds) | Experimental | Injection of Art Filler Universal in nasolabial folds Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
| Art Filler Lips (lips volume) | Experimental | Injection of Art Filler Lips in lips Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
| Art Filler Lips (very deep nasolabial folds) | Experimental | Injection of Art Filler Lips in very deep nasolabial folds Receives: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction on D21 assessed with the global clinical aesthetic score
Objectively measure the improvement according to a global Aesthetic clinical scoring from D0 to D21 of
- after injection of Art Filler Fine lines
- forehead wrinkles (at least 30 subjects)
- upper lip wrinkles (at least 30 subjects)
- cheek folds (at least 30 subjects)
- crow's feet wrinkles (30 subjects)
- after injection of Art Filler Universal
- lips volume (at least 30 subjects)
- nasolabial folds alone or with marionette wrinkles (at least 30 subjects)
- after injection of Art Filler Lips
- lips volume (at least 30 subjects)
- Very deep nasolabial folds alone or with marionette wrinkles (at least 30 subjects)
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 posted1 Dec 2020
- Study start12 Apr 2019
- Primary completion4 Jul 2019
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Face VolumeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips). To this end, subjects in whom a correction of at least one of the studied zones 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. Around 200 subjects aged more than 19 years old with following distribution: * Art Filler Fine Lines * Forehead wrinkles * Upper lip wrinkles * Cheek folds * Crow's feet wrinkles * Art Filler Universal * Volume of the lips (for soft volumizing effect) * Nasolabial folds alone or with marionette lines * Art Filler Lips * Volume of the lips (for plumped lips) * Very deep Nasolabial folds alone or with marionette lines
- Masking
- None (open label)
- Enrolment
- 232 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
- NCT04647513
- Sponsor's protocol ID
- AF4:2018-A02466-49
- Acronym
- AF4
- Status last verified
- Mar 2022
- First submitted
- 23 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 Three Injectable Hyaluronic Acid-based Fillers: Art Filler® Fine Lines, Art Filler® Universal and Art Filler® Lips
- ClinicalTrials.gov ID
- NCT04647513
- Acronym / sponsor ID
- AF4 / AF4:2018-A02466-49
- Conditions
- Loss of Face Volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Laboratoires FILLMEDIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 1 Dec 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 and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies.
In this context, it is proposed to carry out in post-CE marking, an open, prospective and non-comparative study in order to document an adequate aesthetic correction of the most frequent areas treated with Art Filler Fine Lines, Art Filler Universal and Art Filler Lips as well as their immediate and long-term tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips). To this end, subjects in whom a correction of at least one of the studied zones 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. Around 200 subjects aged more than 19 years old with following distribution: * Art Filler Fine Lines * Forehead wrinkles * Upper lip wrinkles * Cheek folds * Crow's feet wrinkles * Art Filler Universal * Volume of the lips (for soft volumizing effect) * Nasolabial folds alone or with marionette lines * Art Filler Lips * Volume of the lips (for plumped lips) * Very deep Nasolabial folds alone or with marionette lines
| Arm | Type | Receives |
|---|---|---|
| Art Filler Fine Lines (forehead) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Fine Lines in Forehead wrinkles |
| Art Filler Fine Lines (upper lip) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Fine Lines in upper lip wrinkles |
| Art Filler Fine Lines (cheek folds) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Fine Lines in cheek folds |
| Art Filler Fine Lines (crow's feet) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Fine Lines in crow's feet |
| Art Filler Universal (lips volume) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Universal in lips |
| Art Filler Universal (nasolabial folds) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Universal in nasolabial folds |
| Art Filler Lips (lips volume) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Lips in lips |
| Art Filler Lips (very deep nasolabial folds) | Experimental | Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)Injection of Art Filler Lips in very deep nasolabial folds |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subjects who had signed a written informed consent
- Man or Woman aged ≥ 19 years old
- Subject having a Fitzpatrick Phototype I to IV
- Subject having a score of ≥ 1 in the Global aesthetic scale scoring system on at least one area of interest (forehead wrinkles, upper lip wrinkles, cheek folds, crow's feet wrinkles, nasolabial folds and/or marionette wrinkles) and/or ≤ 2 for the lip volume
- Subject having at least one of the following scales by clinical scoring
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 has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including 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 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 |
|---|---|---|
| Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies. | Device | Art Filler Fine Lines (cheek folds), Art Filler Fine Lines (crow's feet), Art Filler Fine Lines (forehead), Art Filler Fine Lines (upper lip), Art Filler Lips (lips volume), Art Filler Lips (very deep nasolabial folds), Art Filler Universal (lips volume), Art Filler Universal (nasolabial folds) |
Primary outcome
Correction on D21 assessed with the global clinical aesthetic score
Time frame: D21 (21 days after the injections)
Objectively measure the improvement according to a global Aesthetic clinical scoring from D0 to D21 of * after injection of Art Filler Fine lines * forehead wrinkles (at least 30 subjects) * upper lip wrinkles (at least 30 subjects) * cheek folds (at least 30 subjects) * crow's feet wrinkles (30 subjects) * after injection of Art Filler Universal * lips volume (at least 30 subjects) * nasolabial folds alone or with marionette wrinkles (at least 30 subjects) * after injection of Art Filler Lips * lips volume (at least 30 subjects) * Very deep nasolabial folds alone or with marionette wrinkles (at least 30 subjects)
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 Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) in people with Loss of Face Volume, 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 24 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?
Correction on D21 assessed with the global clinical aesthetic score (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.