| Eligibility |
Inclusion Criteria:
- Healthy Subject;
- Male or female, over the age of 21;
- Seeking an aesthetic procedure on the face and can be classified into one of the
following groups:
1. Group1: Lip volume deficit with ROSSI score between 1.5 and 3 on at least the
upper lip, or on both the upper and the lower lips with up to 1 point difference
in ROSSI score between upper and lower lips;
2. Group 2: Moderate to severe nasolabial folds (NLFs) with WSRS scale score 3 or 4
for each side of the face;
3. Group 3: Mild to significant volume deficit at the cheeks level with MFVDS score
2 to 4 at each side, with up to 1 point difference in MFVDS scale score between
the two sides.
Investigator Live-Evaluator (ILE) and Injector must independently agree that the
criteria is met, however concordance of the scores is not required.
- Willing to abstain from any aesthetic treatment on the face other than the treatments
planned in the protocol during the study period.
Exclusion Criteria:
- Anything on the treatment site which might interfere with the evaluation (tattoo,
scar, moles, too many hairs).
- Subject with mid-face 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, and/or severe
malocclusion or dentofacial or maxillofacial deformities.
- Known history of multiple allergies, allergic/anaphylactic reactions including allergy
to lidocaine or anaesthetics of the amide type, to hyaluronic acid products, or to
Grampositive bacterial proteins.
- Inflammatory and/or infectious cutaneous disorders in or near the treatment area
(herpes, acne, mycosis, papilloma, rosacea, blotches or other pathology on the
treatment area, at the investigator appreciation). Subject with recurrent herpes is
not eligible even if asymptomatic at time of inclusion.
- History or current autoimmune disease and/or immune deficiency.
- History of streptococcal disease (such as acute rheumatic fever or recurrent sore
throats), precancerous lesions/skin malignancies, hyper- or hypo-pigmentation in face.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding
disorders.
- Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic
medications (e.g., warfarin), anti-inflammatory drugs [oral/injectable corticosteroids
or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, e.g., aspirin, ibuprofen)], or other
substances known to increase coagulation time from 10 days pre- to 3 days post
injection [Study device injections may be delayed as necessary to accommodate this
10-day washout period.]
- Have received at any time permanent facial implants (e.g. polyacrylamide, silicone)
anywhere in the face or neck.
- Botulinum toxin injections, mesotherapy, or resurfacing (laser, photomodulation,
intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative
or non-ablative procedures) within 6 months prior to entry in the study.
- Have received injection with a temporary bioresorbable facial dermal filler (e.g.,
hyaluronic acid, collagen, autologous fat, etc.) within the past 12 months prior to
study start.
- Have undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite,
poly-L-lactic acid, etc.) in the face within 24 months before enrolment.
- Have received at any time a treatment with tensor threads or gold strands on the face.
- Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen
during the study.
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