| Eligibility |
Inclusion Criteria:
- Adult subjects aged 18-65 years
- Females or males
- Having any Fitzpatrick skin types I-VI
- Any races and ethnicities
- Having any self-assessed pain tolerance, with a minimum of 5 subjects in each category
(low, medium, and high pain tolerance)
- Subject with intent to undergo correction of the glabellar lines (frown lines between
the eyebrows)
- Subject with moderate-to-severe glabellar lines as assessed by investigator using
Glabellar Line Severity Scale (GLSS).
- Subject with no history of aesthetic injection, i.e., botulinum toxin, collagen,
hyaluronic acid, calcium hydroxyapatite, poly L-lactic acid or permanent materials.
- Subject with healthy immune systems
- Subject willing to abstain from any other facial plastic surgical or cosmetic
procedure(s) during the duration of the study.
- For female subjects of childbearing potential, she must not be pregnant, breastfeeding
or planning pregnancy during the course of the study. Subjects must be willing to take
a urine pregnancy test (UPT) prior to all treatment injections.
- Ability of giving consent for participation in the study
- Agreement to adhere to the procedures and requirements of the study and to report to
the site on the day(s) and at the time(s) scheduled for the assessments
Exclusion Criteria:
- Pregnant, breastfeeding, or planning pregnancy during the course of the study,
confirmed by UPT.
- Current smokers or consumer nicotine (e.g., cigarettes, e-cigarettes, vaping device
with pre-filled pods, vapor tank or mod, chewing tobacco)
- History of allergy or hypersensitivity to botulinum toxin type A, human albumin,
lactose, or cow's milk protein
- Subject with signs and symptoms of eyelid or brow ptosis, inability to substantially
lessen glabellar lines by physically spreading them apart, or history or presence of
facial nerve palsy, as judged by the Investigator.
- Previous or present multiple allergies or severe allergies, such as manifested by
anaphylaxis or angioedema, or family history of these conditions.
- Previous aesthetic treatment in the face with any of the following injection prior to
the baseline visit:
1. Botulinum toxin
2. Collagen, hyaluronic acid
3. Calcium hydroxylapatite, poly L-lactic acid, fat or permanent materials
(non-biodegradable)
- Previous treatment/procedure in the face in the previous 2-4 weeks that, in the
Investigator's opinion, would interfere with the study injections and/or study
assessments or exposed the study subject to undue risk by study participation, or
planning to undergo any of these procedures affecting the treatment area at any time
during the study e.g.,
1. Resurfacing (laser, photo modulation, light, radiofrequency, ultrasound, chemical
peel, dermabrasion, or other ablative/non-ablative procedures)
2. Needling or mesotherapy
3. Cryotherapy
- Presence of any disease or lesions near or on the glabellar region, e.g.,
1. Inflammation, active, or chronic infection in or near the treatment area
2. Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex, and
acanthosis
3. Scars or deformities
- History of bleeding disorders or treatment with anticoagulants or inhibitors of
platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs),
omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are
acceptable only as part of a standard multivitamin formulation.
- Planning on having surgeries and/or invasive medical procedures during the course of
the study
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