AgingAF2NCT05456971
Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips
A study testing Art Filler Volume and Art Filler Lips in people with Aging, run by Laboratoires FILLMED.
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?
- Art Filler Volume 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
- 104 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2016to 30 May 2018
- 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
- Adult subjects not under legal protection who have given their written agreement to take part.
- Men or women, 19 years old or older with no upper limit.
- Fitzpatrick phototype, I, II, III or IV.
- Middle 1/3 of the face (cheeks/cheek pads): Score 3 or 4 (moderate to substantial loss of volume in the middle 1/3 of the face) on Medicis Midface Volume Scale (MMVS) AND/OR Lips: Score of 1 to 2 (very thin to thin lips) on the Medicis Lip Fullness Scale (MLFS)
- Subjects seen at least 12 months after any aesthetic surgery procedure to the face.
- Subjects at least 12 months from any corrective aesthetic facial injection (botulin in toxin or any filling agent) in the study regions, i.e. 1/3 of the midface and peri-oral/lip region.
- Subjects who are members of a social security system.
Who cannot join
- Subjects who do not meet the selection criteria.
- Subjects participating in any other clinical study on the assessment of medicinal products or medical devices or subjects who are in the exclusion period following a clinical study.
- Subjects who have received a facial injection/implantation of any non-resorbable filling agent.
- Subjects with skin support devices (tension wires, gold wires or weave) in their face.
- Subjects who have received laser or ultrasound medical treatment, deep chemical peeling or dermabrasion to the face during the previous 3 months or intending to undergo such a treatment to the face during the study.
- Subjects with a known past history of hypertrophic, cheloid or dyschromic scarring.
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- Subjects with a past history of multiple severe allergies or anaphylactic shock.
- Subjects with known hypersensitivity to any of the components of the study devices.
- Subjects with porphyria.
- Subjects with a past history of Streptococcal diseases (recurrent pharyngitis, acute articular rheumatic disease).
- Subjects with hepatocellular impairment and coagulation disorders.
- Subjects treated with medicinal products which reduce or inhibit liver metabolism.
- Subjects with any acquired or congenital blood dyscrasia abnormality.
- Subjects with cardiac conduction abnormalities.
- Subjects with an episode of Herpes lesions on the face which have recovered within less than 4 weeks and with a contraindication to oral antiviral preventative treatment.
- Subjects with facial scarring involving the injection regions.
- Subjects receiving surgical orodental care and/or treatment for infection within 2 months.
- Subjects receiving concomitant treatment (or treatment which has not been stopped for at least 3 months) with oral or injectable corticosteroids (inhaled corticosteroids and local corticosteroid therapy not involving the head or neck are permitted).
- Subjects with concomitant treatment with an immunosuppressant or other chemotherapy treatment.
- Subjects with a past history of radiotherapy to the head and neck within 6 months.
- Subjects with a past history or autoimmune or connective tissue disease.
- Subjects with an acute inflammatory reaction or bacterial or viral infection or seen within 1 month after the end of such an episode.
- Pregnant or breast-feeding women (a urine pregnancy test will be performed before each injection).
- Subjects suffering from epilepsy not controlled by treatment.
- Subjects with a systemic or psychiatric disorder which could compromise their participation.
- Receipt of an NSAID, or high dose vitamin C and/or E within one week.
About this study
Official title: Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips, 2 Fillers Containing Hyaluronic Acid. Study ART FILLER 2
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. Art Filler® Volume and Art Filler Lips are two hyaluronic-based fillers. Both contain 0.3% lidocaine hydrochloride for its anaesthetic properties. The difference between the two devices lies in their viscosity, which must be adapted for the regions being treated and to restoring facial volumes. Midface for Art Filler® Volume and Lips for Art filler® Lips. On this background, a study is conducted to evaluate the long term efficacy and tolerability of Art Filler® Volume and Art Filler® Lips. It is a prospective, non-comparative, multicentre study with long term evaluation (18 months) of the tolerability and assessment of the efficacy of two devices containing hyaluronic acid intended for filling of lines and restoring volume to the face and lips.
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. Art Filler® Volume and Art Filler Lips are two hyaluronic-based fillers. Both contain 0.3% lidocaine hydrochloride for its anaesthetic properties. The difference between the two devices lies in their viscosity, which must be adapted for the regions being treated and to restoring facial volumes. Midface for Art Filler® Volume and Lips for Art filler® Lips. On this background, a study is conducted to evaluate the long term efficacy and tolerability of Art Filler® Volume and Art Filler® Lips. It is a prospective, non-comparative, multicentre study with long term evaluation (18 months) of the tolerability and assessment of the efficacy of two devices containing hyaluronic acid intended for filling of lines and restoring volume to the face and lips.
Primary objective:
- Art Filler® Volume: To confirm the capacity of Art Filler® Volume to restore a midface volume 3 weeks after the first injection or after 6 weeks if a touch-up was performed at 3 weeks. For a given target area (right or left) volume restoration will be deemed to be satisfactory if the Medicis Midface Volume Scale (MMVS) score falls by at least 1 moint compared to the baseline score.
- Art Filler® Lips: To confirm the capacity of Art Filler® Lips to restore volume of the treated lip 3 weeks after the first injection or after 6 weeks if a touch-up was performed at 3 weeks. For each lip treated (upper or lower) volume restoration will be deemed to be satisfactory if the Medicis Lip Fullness Scale (MLFS) score falls by at least 1 point compared to the baseline score.
- Conditions
- Aging
- Being tested
- Art Filler Volume, Art Filler Lips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Filler VolumeDevice
Midface correction with injectable hyaluronic acid based-filler
Art Filler LipsDevice
Lipscorrection with injectable hyaluronic acid based-filler
| Study group | Role | What they receive |
|---|---|---|
| Art filler Volume | Experimental | To confirm the capacity of the VOLUME filler to restore a midface volume 3 weeks after the first injection or after 6 weeks if a touch up was performed at 3 weeks. Receives: Device: Art Filler Volume |
| Art Filler Lips | Experimental | To confirm the capacity of the LIPS filler to restored volume of the treated lip 3 weeks after the first injection or at 6 weeks if a top up at 3 weeks is performed. Receives: Device: Art Filler Lips |
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
To confirm the capacity of Art Filler Volume to restore a midface volume 3 weeks (D21) after the first injection or after 6 weeks if a touch up was performed at 3 weeks. For a given target area (right or left) volume restoration will be deemed to be satisfactory if the MMVS (Medicis Midface Volume Scale) score falls by at least 1 point compared to the baseline score. (Score 1, Fairly full midface to Score 4, Substantial loss of fullness)
Measured: D21 (21 days after the injections)
Volume correction on D21 with Art Filler Lips
To confirm the capacity of the LIPS filler to restored volume of the treated lip 3 weeks (D21) after the first injection or at 6 weeks if a touch up at 3 weeks is performed. For each lip treated (upper or lower), volume restoration will be deemed to be satisfactory if the MLFS (Medicis Lip Fullness Scale) increases by at least 1 point compared to the baseline score. (Score 1, very thin to Score 5, very full)..
Measured: D21 (21 days after the injections)
Secondary outcomes (5)
Description of local tolerability and emergent local and general incidents during a maximum follow up period of 18 months.
For each visit involving an injection, a descriptive analysis of immediate pain experienced (5 point verbal score completed for each target region treated) and effects detected will be performed. These events will be grouped according to the clinician's own wording, by type of event. They will also be categorised as local or systemic events. Their severity, persistence and causal relationship with the procedure will be described.
An overall analysis will also be conducted including all injections administered over the 18 month follow up period. The prevalence of these events will be calculated taking account of the target area for local events.
Measured: 18 months (540 Days after the injections)
Evaluation of persistence of volume-enhancing effect
The MMVS (Medicis Midface Volume Scale) and MFLS (Medicis Lip Fullness Scale) scores for each region injected measured at 3 weeks or at 6 weeks (if a top up is carried out at 3 weeks) after the first injection will define the optimal cosmetic score for a given target region.
Measured: 18 months (540 Days after the injections)
Evaluation of overall cosmetic improvement
Overall cosmetic improvement will be reported for the PP (Per Protocol) population at 3/6 weeks and at 3, 6, 9, 12, 15 and 18 months from the Doctor and subject GAIS (Global Aesthetic Improvement Scale).
Measured: 18 months (540 Days after the injections)
Evaluation of the injection procedures
Description of the procedures and injection volumes of the VOLUME filler and LIPS filler and the technical ease of use of these fillers at each visit involving an injection (for a given visit, the total volume injected will be the sum of the initial injection and any top up at 3 weeks). An overall descriptive analysis will also be conducted taking account of all of the injections administered over the whole follow up period.
Measured: 18 months (540 Days after the injections)
Evaluation of self-esteem by subjects
The evaluation of self-esteem will be determined by using the ETES scale ( "Echelle toulousaine d'estime de soi"). The overall ETES score will be calculated at 6 and 12 months
Measured: 12 months (360 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 posted13 Jul 2022
- Study start12 Sep 2016
- Primary completion29 Dec 2016
- Study completion30 May 2018
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
- Non-randomised
- Intervention model
- Single group
- Model description
- Throughout the study period (18 months), only two products will be used for the aesthetic procedures (Art Filler® Volume and Art Filler® Lips). 100 subjects will be injected in order to have at least 100 midface regions and 100 lips treated and assessed at 3 or 6 weeks for the primary end point.
- Masking
- None (open label)
- Enrolment
- 104 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
- NCT05456971
- Sponsor's protocol ID
- AF2:2016-A00358-43
- Acronym
- AF2
- Status last verified
- Jul 2022
- First submitted
- 29 Mar 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips, 2 Fillers Containing Hyaluronic Acid. Study ART FILLER 2
- ClinicalTrials.gov ID
- NCT05456971
- Acronym / sponsor ID
- AF2 / AF2:2016-A00358-43
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Laboratoires FILLMEDIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 13 Jul 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 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. Art Filler® Volume and Art Filler Lips are two hyaluronic-based fillers. Both contain 0.3% lidocaine hydrochloride for its anaesthetic properties. The difference between the two devices lies in their viscosity, which must be adapted for the regions being treated and to restoring facial volumes. Midface for Art Filler® Volume and Lips for Art filler® Lips. On this background, a study is conducted to evaluate the long term efficacy and tolerability of Art Filler® Volume and Art Filler® Lips. It is a prospective, non-comparative, multicentre study with long term evaluation (18 months) of the tolerability and assessment of the efficacy of two devices containing hyaluronic acid intended for filling of lines and restoring volume to the face and lips.
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. Art Filler® Volume and Art Filler Lips are two hyaluronic-based fillers. Both contain 0.3% lidocaine hydrochloride for its anaesthetic properties. The difference between the two devices lies in their viscosity, which must be adapted for the regions being treated and to restoring facial volumes. Midface for Art Filler® Volume and Lips for Art filler® Lips. On this background, a study is conducted to evaluate the long term efficacy and tolerability of Art Filler® Volume and Art Filler® Lips. It is a prospective, non-comparative, multicentre study with long term evaluation (18 months) of the tolerability and assessment of the efficacy of two devices containing hyaluronic acid intended for filling of lines and restoring volume to the face and lips.
Primary objective:
- Art Filler® Volume: To confirm the capacity of Art Filler® Volume to restore a midface volume 3 weeks after the first injection or after 6 weeks if a touch-up was performed at 3 weeks. For a given target area (right or left) volume restoration will be deemed to be satisfactory if the Medicis Midface Volume Scale (MMVS) score falls by at least 1 moint compared to the baseline score.
- Art Filler® Lips: To confirm the capacity of Art Filler® Lips to restore volume of the treated lip 3 weeks after the first injection or after 6 weeks if a touch-up was performed at 3 weeks. For each lip treated (upper or lower) volume restoration will be deemed to be satisfactory if the Medicis Lip Fullness Scale (MLFS) score falls by at least 1 point compared to the baseline score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Throughout the study period (18 months), only two products will be used for the aesthetic procedures (Art Filler® Volume and Art Filler® Lips). 100 subjects will be injected in order to have at least 100 midface regions and 100 lips treated and assessed at 3 or 6 weeks for the primary end point.
| Arm | Type | Receives |
|---|---|---|
| Art filler Volume | Experimental | Device: Art Filler VolumeTo confirm the capacity of the VOLUME filler to restore a midface volume 3 weeks after the first injection or after 6 weeks if a touch up was performed at 3 weeks. |
| Art Filler Lips | Experimental | Device: Art Filler LipsTo confirm the capacity of the LIPS filler to restored volume of the treated lip 3 weeks after the first injection or at 6 weeks if a top up at 3 weeks is performed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult subjects not under legal protection who have given their written agreement to take part.
- Men or women, 19 years old or older with no upper limit.
- Fitzpatrick phototype, I, II, III or IV.
- Middle 1/3 of the face (cheeks/cheek pads): Score 3 or 4 (moderate to substantial loss of volume in the middle 1/3 of the face) on Medicis Midface Volume Scale (MMVS) AND/OR Lips: Score of 1 to 2 (very thin to thin lips) on the Medicis Lip Fullness Scale (MLFS)
- Subjects seen at least 12 months after any aesthetic surgery procedure to the face.
Key exclusion criteria (26 listed)
- Subjects who do not meet the selection criteria.
- Subjects participating in any other clinical study on the assessment of medicinal products or medical devices or subjects who are in the exclusion period following a clinical study.
- Subjects who have received a facial injection/implantation of any non-resorbable filling agent.
- Subjects with skin support devices (tension wires, gold wires or weave) in their face.
- Subjects who have received laser or ultrasound medical treatment, deep chemical peeling or dermabrasion to the face during the previous 3 months or intending to undergo such a treatment to the face during 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 |
|---|---|---|
| Art Filler VolumeMidface correction with injectable hyaluronic acid based-filler | Device | Art filler Volume |
| Art Filler LipsLipscorrection with injectable hyaluronic acid based-filler | Device | Art Filler Lips |
Primary outcome
Volume correction on D21 with Art Filler Volume
Time frame: D21 (21 days after the injections)
To confirm the capacity of Art Filler Volume to restore a midface volume 3 weeks (D21) after the first injection or after 6 weeks if a touch up was performed at 3 weeks. For a given target area (right or left) volume restoration will be deemed to be satisfactory if the MMVS (Medicis Midface Volume Scale) score falls by at least 1 point compared to the baseline score. (Score 1, Fairly full midface to Score 4, Substantial loss of fullness)
Volume correction on D21 with Art Filler Lips
Time frame: D21 (21 days after the injections)
To confirm the capacity of the LIPS filler to restored volume of the treated lip 3 weeks (D21) after the first injection or at 6 weeks if a touch up at 3 weeks is performed. For each lip treated (upper or lower), volume restoration will be deemed to be satisfactory if the MLFS (Medicis Lip Fullness Scale) increases by at least 1 point compared to the baseline score. (Score 1, very thin to Score 5, very full)..
5 secondary outcomes
Description of local tolerability and emergent local and general incidents during a maximum follow up period of 18 months.
Time frame: 18 months (540 Days after the injections)
Evaluation of persistence of volume-enhancing effect
Time frame: 18 months (540 Days after the injections)
Evaluation of overall cosmetic improvement
Time frame: 18 months (540 Days after the injections)
Evaluation of the injection procedures
Time frame: 18 months (540 Days after the injections)
Evaluation of self-esteem by subjects
Time frame: 12 months (360 Days after the injections)
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 13 Jul 2022.
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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
Questions about this trial
What is this clinical trial studying?
A study testing Art Filler Volume and Art Filler Lips in people with Aging, run by Laboratoires FILLMED.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: D21 (21 days after the injections)). The study lists 2 primary outcomes in all. 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 13 Jul 2022.