| Eligibility |
Inclusion Criteria:
1. Completed Protocol PRO 2018-03 OR Protocol PRO 2018-02 and did not enroll in Protocol
PRO 2018-03.
2. Men or non-pregnant or non-breastfeeding women over 21 years of age
3. At PRO 2018-02 baseline visit had an overall score of very thin, or thin on the LFGS,
as agreed upon by the Treating and Evaluating Investigators, and desires at least a
1-point improvement in overall LFGS score; OR Had a Fitzpatrick skin phototype IV, V
or VI and has an LFGS score of thick or full, as agreed upon by the Treating and
Evaluating Investigators, and desires treatment to the vermilion body of 1 or both
lips
4. If female and of childbearing potential, a negative urine pregnancy test at Visit
1/Day 1 and the subject agrees to use adequate contraception during the study period.
5. Willing to give written informed consent.
Exclusion Criteria:
1. Women who are pregnant, lactating, or planning a pregnancy.
2. Subjects with a known history of allergy, anaphylaxis or hypersensitivity to
injectable hyaluronic acid products, local anesthetics of the amide type such as
lidocaine, or to latex.
3. Subjects with a significant ongoing adverse event from PRO 2018-02 or PRO 2018-03 that
in the opinion of the investigator could be worsened by participation in this study.
4. Subjects that experienced an SAE, AESI, visual changes or other serious medical
conditions during PRO 2018-02 or PRO 2018-03
5. Subjects who are unable to withhold thrombolytics, or inhibitors of platelet
aggregation or nonsteroidal anti inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen)
or other substances known to increase coagulation time (e.g., herbal supplements with
garlic or gingko) within 10 days before AND after any injection session.
6. Subjects with clinically significant organic disease including clinically significant
cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical
condition, serious intercurrent illness, or extenuating circumstance that, in the
opinion of the investigator, preclude participation in the trial.
7. Subjects with lip tattoos, piercings, facial hair, or scars that would interfere with
visualization of the lips and perioral area for the effectiveness assessments.
8. Subjects with abnormal lip function, with inability to effectively sip water through a
straw.
9. Subjects with abnormal lip sensation with inability to feel a 0.4G monofilament or a
cotton wisp at any site on the lip.
10. Subjects with moderate or severe abnormal lip asymmetry.
11. Subjects with any mass formation on the lip.
12. Subjects with dentures or any device covering all or part of the upper palate, and/or
severe malocclusion or dentofacial or maxillofacial deformities as judged by the
Treating Investigator. Subjects planning to undergo extensive dental procedures such
as dental implants, multiple tooth extractions, or oral surgery should not
participate. Minor dental procedures such as teeth cleaning and repair of caries are
not exclusionary.
13. Subjects that have undergone facial plastic surgery or received permanent facial
implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene,
polyacrylamide, lifting threads) anywhere in the face or neck, or are planning to be
implanted with any of these products during the study.
14. Subjects that have undergone semi-permanent dermal filler treatment (e.g., calcium
hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within
12 months before enrollment or are planning to undergo such treatment during the
study.
15. Subjects that have undergone facial tissue augmentation with fat injections, botulinum
toxin injections in the lower face (below the orbital rim), mesotherapy, or cosmetic
procedures in the face or neck (e.g., face-lift, laser, photo-modulation, intense
pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel,
microneedling, or other ablative procedures) within 9 months before enrollment or are
planning to undergo any of these procedures during the study.
16. that have used ANY lip filling agents within 12 months of study enrollment (hyaluronic
acid products, collagen-based products, etc.) other than Investigational Device
administered in PRO 2018-02 and PRO-2018-03.
17. Subjects that have used any lip plumping products or devices within 10 days before
enrollment or are planning to use such products during the study.
18. Subjects that have begun using any over-the-counter (OTC) or prescription oral or
topical anti wrinkle products for the lips or around the mouth within 90 days before
enrollment or are planning to begin using such products during the study (Subjects who
have been on a stable regimen of such products for at least 90 days are eligible for
the study and must continue their regimen throughout the study).
19. Subjects that have a history or presence of bleeding disorders.
20. Subjects that have used systemic corticosteroids or immunosuppressive medications
within 30 days prior to treatment.
21. Subjects that are on a concurrent regimen of lidocaine or structurally related local
anesthetics (e.g., bupivacaine)
22. Subjects that have an active inflammation (skin eruptions such as cysts, pimples,
rashes, or hives), infection cancerous or precancerous lesion, or unhealed wound on
the face.
23. Subjects that have a history of known susceptibility to keloid formation or
hypertrophic scars.
24. Subjects that have porphyria.
25. Subjects that have active herpes labialias lesions at the time of injections. Subjects
with a history of herpes labialis who have had four (4) or more outbreaks in the 12
months prior to enrollment are also excluded even in the absence of lesions at the
baseline visit.
26. Subjects that have impaired cardiac conduction, severely impaired hepatic function, or
severe renal dysfunction that, in the opinion of the investigator, would place them at
risk of associated complications from these illnesses during the course of the study.
27. Subjects that have any uncontrolled disease, i.e., a condition that has not been
appropriately diagnosed, evaluated, and received medically appropriate treatment or
care
28. Subjects that have severe cardiovascular disease; examples include but are not limited
to New York Heart Association heart failure classification III or IV, unstable angina,
and internal pacemakers. Potential subjects with other significant cardiovascular
diseases should be discussed with the Medical Monitor before enrolling.
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