| Eligibility |
Inclusion Criteria:
1. Male or female adults 18 to 65 years of age (inclusive).
2. Subjects whose volume of the overall lips corresponds to score of 0 (none/minimal), 1
(mild), 2 (moderate), or 3 (pronounced) of the 5-point LFRS as assessed by the blinded
Evaluating Investigator at Visit 1 (Screening).
3. Subjects who want a filler injection procedure for at least a 1-grade increase on the
overall LFRS score after treatment.
4. Subjects who are informed of the purpose, method, and effectiveness of the clinical
investigation and who sign the written informed consent form (ICF).
5. Except for surgically sterile male or female subjects, and female subjects with
natural menopause (without drug intervention) for more than 2 years after last
menstruation, other male or female subjects must agree to use an effective method
throughout the entire clinical investigation period to prevent pregnancy
Exclusion Criteria:
1. Subjects who have lip tattoos, piercings, facial hair, or scars that would interfere
with visualization of the lips and perioral area.
2. Subjects who have dentures or any device covering all or part of the upper palate,
and/or severe malocclusion or dentofacial or maxillofacial deformities.
3. Subjects who have undergone oral surgery (e.g., tooth extraction, orthodontia, or
implantation) within 6 months before enrollment or is planning to undergo any of these
procedures during the clinical investigation.
4. Subjects who have received permanent facial implants or fillers (e.g.,
polymethylmethacrylate, silicone, polytetrafluoroethylene, autologous fat) in the face
or neck, or are planning to be implanted with any of these products during the
clinical investigation.
5. Subjects who have received non-permanent filler treatment in the lower face (below the
orbital rim) or are planning to undergo during the clinical investigation, including
but not limited to receiving calcium hydroxylapatite or poly-L lactic acid within 24
months before enrollment, or hyaluronic acid [HA] or collagen within 12 months before
enrollment.
6. Subjects who have undergone the following procedure within 6 months before enrollment
or are planning to undergo during the clinical investigation: Facial tissue
augmentation or facial treatment with fat or botulinum injections in the lower face
(below the orbital rim). messotherapy, face lift, stripping laser, dermabrasion,
moderate or greater depth chemical peel, or other ablative procedures in face or neck.
7. Subjects who have used non-implantable lip plumping products within 10 days before
enrollment anywhere in the treatment area or are planning to receive such
treatment/intervention during the clinical investigation participation.
8. Subjects who have used any over-the-counter or prescription, oral or topical
anti-wrinkle products for the lips or around the mouth within 3 months before
enrollment or are planning to use such products during the clinical investigation.
9. Subjects who are on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or
non-steroidal anti-inflammatory drugs (NSAIDs; e.g., aspirin, ibuprofen) or other
substances known to increase coagulation time (e.g., herbal supplements with gingko
biloba) within 10 days of undergoing investigational medical device injections.
10. Subjects who have history of anaphylaxis, multiple several allergies, or allergy to
lidocaine, or amide local anesthetics, HA products, or Streptococcal protein, or are
planning to undergo desensitization therapy during the clinical investigation.
11. Subjects with active inflammation, infection sites or unhealed wound in the mouth
area.
12. Subjects who have history of herpetic eruption.
13. Subjects who have history of bleeding disorder based on the coagulation laboratory
test results (international normalized ratio [INR], prothrombin time, and activated
partial thromboplastin time [aPTT]) as per Investigator's discretion.
14. Subjects with abnormal laboratory assessment and judged clinically significant per
Investigator's discretion (e.g., alanine aminotransferase [ALT] = 2.5×upper limit of
normal [ULN], aspartate aminotransferase [AST] = 2.5×ULN).
15. Subjects who have porphyria.
16. Subjects who have a tendency to develop hypertrophic scar or keloid.
17. Subjects who have severe cardiovascular, hepatic or renal diseases considered as per
Investigator's discretion.
18. Subjects who have malignant tumors or cancerous or precancerous lesion which could
affect the clinical investigation.
19. Subjects who have untreated epilepsy.
20. Subjects who are ineligible for this clinical investigation as per Investigator's
discretion.
21. Subjects who have participated in another clinical investigation within 1 month prior
to Visit 1 (Screening).
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