| Eligibility |
Inclusion Criteria:
1. Males or non-pregnant, non-breastfeeding females, 22 to 65 years old.
2. Sign the Informed Consent form and the Authorization for Use and Release HIPAA form
prior to any study-related procedures being performed.
3. Willing to comply with the requirements of the study, including sequential photography
or imaging; willing to abstain from any plastic surgical or cosmetic procedures of the
head or neck for the 24 months of the study (including but not limited to laser or
chemical resurfacing, facelift, and other filler treatments).
4. Willing to avoid any intentional changes in weight, and avoid initiating any strict
weight loss or weight gain programs.
5. Agrees to refrain from seeking other treatment for the treated condition during
thestudy.
6. If the subject is a female of childbearing potential (sexually active and not sterile
nor postmenopausal for at least 1 year), she must have a negative urine pregnancy test
have used an acceptable contraception method for at least 30 days prior to enrollment,
and agree to use an acceptable method of contraception for the duration of the study.
The following are considered acceptable methods of birth control for the purpose of
this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal
contraceptive (NuvaRing®), double barrier methods (e.g., condom and spermicide),
contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD
(Mirena®), and abstinence with a documented second acceptable method of birth control
if the subject becomes sexually active.
Inclusion Criteria Specific for Treatment Indications:
Cheek Augmentation:
8. Seeking augmentation therapy for the midface with a Midface Volume Scale (MFVS) score of
a 1 (mild loss midface volume loss and or presence of mild concavity) or 2 (moderate
midface volume loss and/or presence of moderate concavity) on each side of the face as
assessed by the Treating Investigator.
9. Accept the obligation not to receive any other facial procedures or treatments affecting
facial volume deficit at any time during the study.
Nasolabial Fold Correction:
10. Seeking augmentation therapy for the nasolabial folds with two fully visible nasolabial
folds with Wrinkle Severity Rating Scale score of 3 or 4 (moderate or severe).
11. Accepts the obligation not to receive any other facial procedures or treatments
affecting facial nasolabial fold deficit at any time during the study.
Exclusion Criteria:
1. Female subjects who are pregnant, breastfeeding, intending to become pregnant during
the study, or who do not agree to use an acceptable form of birth control during the
study.
2. Subjects who have a body mass index (BMI) of = 30.
3. A history of allergy or hypersensitivity to injectable hyaluronic acid gel.
4. A history of allergy or hypersensitivity to silk.
5. Presentation on the face of any of the following: cysts, acne, rosacea, rashes or
hives, infection, psoriasis, herpes zoster, actinic keratosis or any other disease
that , in the opinion of the investigator, may result in changes in facial contour,
edema of the face or otherwise interfere with study assessments.
6. Subjects who have undergone the following: 1) chemical peels, 2) microdermabrasion, 3)
dermabrasion, or 4) needling procedures anywhere on the face or neck within 6 months
prior to study treatment and throughout the study.
7. Subjects who received injectable neurotoxins on the face or neck area within 6 months
prior to study treatment and throughout the study.
8. Subjects who have undergone facial treatment with a hyaluronic acid (HA) tissue filler
within 12 months prior to study treatment and throughout the study.
9. Subjects who used deoxycholic acid treatment or other fat-reducing agents within 12
months prior to study treatment and throughout the study.
10. Subjects who have undergone mesotherapy, highintensity focused ultrasound (HIFU),
high-intensity focused electromagnetic energy (HIFEM), or any other Energy Based
Devices on the face within 12 months of the study and throughout the study. This also
includes all intense pulsed light treatments, lasers (all), and RF treatments of any
kind, photodynamic therapy, photomodulation with low level light sources (including
laser light).
11. Subjects who have undergone facial treatment with a non-HA tissue filler (e.g.,
collagen, calcium hydroxylapatite, Poly-L-lactic Acid) within 18 months prior to study
treatment and throughout the study.
12. Subjects who have ever undergone facial plastic surgery, tissue grafting, or received
permanent facial implants (e.g., polymethyl methacrylate, polyacrylamide, silicone,
fat transfer procedures or adipose matrix products, polytetrafluoroethylene, lifting
threads, absorbable sutures) anywhere in the face or neck, or is planning to be
implanted with any of these products during the course of the study.
13. Subjects who have 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.
14. Evidence of scar-related disease or delayed healing activity within the past 12
months.
15. Evidence of scar at the intended treatment region on the face.
16. History of keloid formation or hypertrophic scars.
17. History of bleeding disorders or connective tissue disorders or granulomatous diseases
(sarcoidosis etc).
18. Presence of any wound or infection on the face.
19. Subjects with a midface volume deficit due to congenital defect, trauma, abnormalities
in adipose tissue related to immune-mediated diseases such as generalized
lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g.,
Barraquer-Simons syndrome), inherited disease, or HIV-related disease or HIV therapy.
20. The presence of any contraindication to the implant procedures in a relevant period
before study entry (per the Treating investigator's judgment).
21. Subjects on the following therapy within 10 days of undergoing study device
injections: a) prescribed anticoagulation therapy, thrombolytics, or inhibitors of
platelet aggregation. Subjects are advised not to stop their prescribed therapy
without consultation with their treating physician or primary care physician; b)
nonsteroidal anti-inflammatory drugs (NSAIDs), or other substances known to increase
coagulation time (e.g., herbal supplements with garlic or gingko, Vitamin E in excess
of 50 IU per day). Subjects who will withhold such therapy for 10 days before AND
after any injection session may participate.
22. Subjects on systemic (oral/injectable) corticosteroids or immunomodulatory/
immunosuppressive medications within 30 days prior to treatment. Subjects using
topical steroids on the face within 14 days prior to treatment start and throughout
the study.
23. Use of prescription wrinkle treatment (example: topical retinoids) or topical
adapalene within 4 weeks (28 days) prior to treatment and throughout the study. Use of
sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids,
glycolic acids, or retinol-containing products) is allowed if the regimen was
established = 90 days prior to enrollment.
24. A history of severe allergies or multiple allergies manifested by anaphylaxis.
25. The presence of any condition that, in the opinion of the investigator, makes the
subject unable to complete the study per protocol (e.g., subject not likely to avoid
other facial cosmetic treatments).
26. Subjects not likely to stay in the study for up to 24 months because of other
commitments, concomitant conditions, or past history.
27. Subjects with facial tattoo or facial hair that may interfere with diagnosis or
evaluation of treatment.
28. The presence of known allergies, uncommon resistance, or hypersensitivity reactions to
local topical anesthetics or nerve blocking agents (if such products are intended to
be used for that subject).
29. History of or presence of cancerous or pre-cancerous lesions in the area to be
treated.
30. Subjects who are immunocompromised or immunosuppressed.
31. Subjects who are employed by (or a relative of) the Treating Investigator, Site staff,
Sponsor, or representative of the Sponsor.
32. Have received any investigational product within 30 days prior to study enrollment or
be planning to participate in another investigation during the course of this study.
33. Subjects anticipated to be unreliable; or subjects who have a concomitant condition
that might confuse or confound study treatments or assessments in the opinion of the
investigator.
34. Subjects with "unattainable expectations."
Exclusion Criteria Specific for Treatment Indication:
Cheek Augmentation:
35. Subjects with an MFVS score of 0 (none to minimal midface volume loss with no apparent
concavity) or 3 (severe midface volume loss and or severe concavity with apparent bony
prominence) on the right or left midface as rated by the Treating Investigator.
Nasolabial Fold Correction:
36. Subjects with a WSRS score of = 2 (absent or mild) on the right or left nasolabial
fold as rated by the Treating Investigator.
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