| Eligibility |
Inclusion Criteria: (baseline treatment)
1. Male or female subjects aged 22 - 75 years (inclusive) of age at Screening.
2. Subjects with bilateral, approximately symmetric moderate to severe midface volume
deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity
Scale), as assessed by the blinded investigator at the site.
3. Females of childbearing potential must have a negative urine pregnancy test and must
agree to use a highly effective method of birth control throughout the entire study.
Males subjects with female partners of child-bearing potential must agree to use
contraception throughout the entire study (surgical sterilization or a physical
barrier such as a condom).
4. Healthy skin in the midface area and free of diseases that could interfere in
cutaneous aging evaluation.
5. Willingness to abstain from any aesthetic or surgical procedures in the treatment area
for the duration of entire investigation, including botulinum toxin injection (except
glabella or forehead botulinum toxin treatment).
6. Subjects who understand the purpose and conduct of the study and having given written
informed consent and are willing and able to attend the study visits as judged by the
investigator.
Exclusion Criteria: (baseline treatment)
1. Females, who are pregnant and/or, lactating or planning to become pregnant during the
clinical investigation
2. History of severe allergies manifested by a history of anaphylaxis or history or
presence of multiple severe allergies
3. History of hypersensitivity to hyaluronic acid preparations, lidocaine or any
amide-based anesthetic
4. Tendency to keloid formation and/or hypertrophic scars and/ or have pigment disorders
5. Known human immune deficiency virus-positive individuals
6. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous
lesions in the treatment area
7. Re-current (three times a year over the last year) herpes simplex in the treatment
area
8. History or presence of any autoimmune or connective tissue disease, or current
treatment with immuno-modulating therapy
9. Uncontrolled (or unstable) Diabetes mellitus or systemic diseases as per investigator
discretion
10. Previous facial plastic surgery, tissue augmentation with silicone, fat or another
non-absorbable substance (permanent fillers) and semi-permanent / long-lasting fillers
(e.g., poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA) filler) in the area of
device application and during the entire investigation
11. Implantation of dermal fillers in the treatment area within the preceding 24 months
prior to Visit 1 (Screening) and during the entire investigation
12. Subject has received any of the following aesthetic treatments in the midface area:
e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion,
mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet
in the outer eye region) within the last 12 months prior to Visit 1, chemical peeling
within the last three months prior to Visit 1 or is planning to undergo such
procedures during entire investigation.
13. Facial lipolysis, including submental fat treatments, within the previous 12 months
prior to Visit 1 (Screening) and during the entire investigation
14. Bariatric surgery within 12 months prior to Visit 1 (Screening) and during the entire
investigation
15. History of bleeding disorder and/or use of anticoagulant, antiplatelet, thrombolytic
medication, or anti-inflammatory drugs (oral/injectable corticosteroids or non
steroidal anti-inflammatory drugs, e.g., Motrin® or Advil®) or other substances known
to increase coagulation time (vitamins or herbal supplements, e.g., St. John's Wort,
high doses of vitamin E supplements) from ten days pre- to seven days post injection
(baseline treatment and touch-up treatment)
16. Planned dental/oral surgery or modification (bridge-work, implants) within four weeks
prior to each injection and to a minimum of four weeks post injection baseline
treatment and touch-up treatment
17. Beard longer than three-day beard, or excessive facial hair that could interfere in
evaluation of treatment as judged by the investigator
18. Subjects who have one of the following assessments during the visual examinations at
Visit 2 (Baseline): Snellen visual acuity test worse than 20/40 (with corrective
eyewear, if applicable), abnormal confrontational visual field test, or abnormal
ocular motility test.
19. Subjects with active COVID-19 infection and subjects with symptoms consistent with
COVID-19 infection including any other respiratory symptoms/illnesses within the past
14 days unless tested negative prior to Visit 1 (Screening)
20. Any medical condition prohibiting the inclusion in the study according to the judgment
of the treating investigator
21. Previous enrollment in this clinical investigation
22. Current participation in another clinical trial, or treatment with any investigational
drug/medical device within 30 days prior to Visit 1 (Screening) or within five
half-lives of an investigational drug, whichever is longer and during the entire
investigation
23. Midface volume deficit due to a congenital defect, trauma, or abnormalities in facial
adipose tissue distribution such as those associated with HIV related lipodystrophy
24. Subjects who experienced fat loss for a minimum of 10% of body weight over the last 12
months (e.g., post bariatric patients), or subjects who have the intention to change
eating habits that result in a weight gain or loss >10% during the entire
investigation
25. Any individual whose willingness to volunteer in this clinical investigation could be
unduly influenced by the expectation, whether justified or not, of benefits associated
with participation or of retaliatory response from senior members of a hierarchy in
case of refusal to participate (e.g., persons with a legal custodian appointed due to
mental disability, prisoners, soldiers and other members of the armed forces, civil
servants).
26. Close affiliation with the investigator (e.g., a close relative, financially dependent
on the study site) or subject who is an employee of the sponsor's company or group
companies of the sponsor.
Inclusion criteria: (touch-up treatment)
1. Females of childbearing potential must have a negative urine pregnancy test
Exclusion criteria: (touch-up treatment)
1. Occurrence of a serious adverse event or Adverse Event of Special Interest (i.e.,
changes in vision [loss of vision, blurriness, double vision, pain in or around the
eye, blindness, blind spots, problems moving the eyes], skin changing color around the
eyelids or around the site of injection, other embolic phenomenon, e.g., stroke)
during or after the previous injection
2. Subjects who experienced visual changes considered abnormal clinically significant or
other serious medical conditions during or after the previous injections
3. Subjects who have one of the following assessments during the visual examinations:
Snellen acuity test worse than 20/40 (with corrective eyewear, if applicable),
abnormal confrontational visual field test, or abnormal ocular motility test.
Inclusion criteria: (repeat-treatment)
1. Subjects with bilateral, approximately symmetric moderate to severe midface volume
deficit (severity scores of 2 or 3 on the 5-point MVDSS), as assessed by the blinded
evaluator at the site. The subject does not have to return to his baseline severity to
be permitted to receive a repeat-treatment.
2. Subject has completed initial treatment phase up to Visit 9 (SV1)
3. Females of childbearing potential must have a negative urine pregnancy test
4. Healthy skin in the midface area and free of diseases that could interfere in
cutaneous aging evaluation
Exclusion criteria: (repeat-treatment)
1. Occurrence of a related Serious Adverse Event or Adverse Event of Special Interest
(i.e., changes in vision [loss of vision, blurriness, double vision, pain in or around
the eye, blindness, blind spots, problems moving the eyes], skin changing color around
the eyelids or around the site of injection, other embolic phenomenon, e.g., stroke)
during or after the baseline injection and/or touch-up injections
2. Occurrence of a related Adverse Event that occurred during the initial treatment
phase, and is ongoing at the time of the repeat treatment (i.e., relationship is
classified as "possible", "probable" or "causal relationship"; outcome is "not
recovered / resolved", "recovering / resolving", "recovered / resolved with sequelae"
or "unknown")
3. Subjects who experienced visual changes considered abnormal clinically significant or
other serious medical conditions during or after the baseline or touch-up injections,
respectively
4. Subjects who have one of the following assessments during the visual examinations:
Snellen acuity test worse than 20/40 (with corrective eyewear, if applicable),
abnormal confrontational visual field test, or abnormal ocular motility test
5. Subjects who became pregnant since start of the study or planning to become pregnant
during the clinical investigation
6. Known human immune deficiency virus-positive individuals
7. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous
lesions in the treatment area
8. Development of re-current (three times a year over the last year) herpes simplex in
the treatment area since study start
9. Development of any autoimmune or connective tissue disease since study start, or
current treatment with immuno-modulating therapy
10. Development of uncontrolled (or unstable) diabetes mellitus or systemic diseases since
study start as per investigator discretion
11. Facial plastic surgery, tissue augmentation with silicone, fat or another
non-absorbable substance (permanent fillers) and semi-permanent fillers (e.g.,
poly-L-lactic acid) in the area of device application and during the initial treatment
phase of the investigation
12. Implantation of dermal fillers (other than the test and comparator device used in the
investigation) in the treatment area during the initial treatment phase of the
investigation
13. Subject has received any of the following aesthetic treatments in the midface area:
e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion,
mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet
in the outer eye region), or chemical peeling during the initial treatment phase of
the investigation or is planning to undergo such procedures during the
repeat-treatment phase of the investigation
14. Facial lipolysis, including submental fat treatments during the initial treatment
phase of the investigation
15. Bariatric surgery during the initial treatment phase of the investigation
16. Development of bleeding disorder and/or use of anticoagulant, antiplatelet,
thrombolytic medication, or anti-inflammatory drugs (oral/injectable corticosteroids
or non steroidal anti-inflammatory drugs, e.g., Motrin® or Advil®) or other substances
known to increase coagulation time (vitamins or herbal supplements, e.g., St. John's
Wort, high doses of vitamin E supplements) from ten days pre- to seven days post
injection (repeat-treatment and touch-up treatment)
17. Planned dental/oral surgery or modification (bridge work, implants) within four weeks
prior to the injection and to a minimum of four weeks post injection
18. Any medical condition prohibiting the inclusion for repeat-treatment according to the
judgement of the treating investigator
19. Beard longer than three-day beard, or excessive facial hair that could interfere in
evaluation of treatment as judged by the investigator
20. Previous enrollment in initial treatment phase of this clinical investigation and
early termination, or significant incompliance with the protocol requirements
21. Current or previous treatment with another investigational drug and/or medical device
or participation in another clinical study
22. Midface volume deficit due to a trauma, or abnormalities in facial adipose tissue
distribution such as those associated with HIV related lipodystrophy
23. Subjects who experienced fat loss for a minimum of 10% of body weight since study
start or subjects who have the intention to change eating habits that result in a
weight gain or loss >10% during the entire investigation
24. Subjects with active COVID-19 infection and subjects with symptoms consistent with
COVID-19 infection including any other respiratory symptoms/illnesses within the past
14 days unless tested negative prior to Visit RT1
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