| Eligibility |
Inclusion Criteria:
1. Male or female subjects of Chinese origin from =18 to =65 years of age.
2. Moderate to severe GL (grade of 2 or 3 on the 4-point Photographic Scale ranging from
0 [none] to 3 [severe]) at maximum frown as assessed by the Investigator (GL-ILA).
3. Moderate to severe GL (grade of 2 or 3 on the Static 4-point Categorical Scale ranging
from 0 [no wrinkles] to 3 [severe wrinkles]) at maximum frown as assessed by the
subject (GL-SLA).
4. Female of non-childbearing potential (i.e., post-menopausal [absence of menstrual
bleeding for 1 year prior to screening, without any other medical reason], or has
undergone hysterectomy or bilateral oophorectomy). OR Female of childbearing potential
with a negative pregnancy test at screening and baseline, and agrees to use a highly
effective and approved contraceptive method for the duration of the study. A highly
effective method of contraception is defined as: Bilateral tubal ligation; Combined
(estrogen and progesterone containing) oral, intravaginal or transdermal
contraceptives that inhibit ovulation as the primary mode of action, on a stable dose
for at least 28 days prior to screening visit; Intrauterine device (IUD) inserted at
least 28 days prior to screening visit; Intrauterine hormone-releasing system; Partner
vasectomized for at least three months prior to screening visit; Progestogen-only
oral, injectable or implantable contraceptives that inhibit ovulation as the primary
mode of action, on a stable dose for at least 28 days prior to screening visit; or
Strict abstinence (i.e., refraining from heterosexual intercourse for the duration of
the subject's participation in the study).
5. Time and ability to complete the study and comply with instructions.
6. Understands the study requirements and signed the informed consent form (ICF).
Exclusion Criteria:
1. Previous use of any botulinum neurotoxin (BoNT) in facial areas within 9 months prior
to study treatment.
2. Anticipated need for treatment with BoNT of any serotype for any reason during the
study (other than the study products).
3. Female who is pregnant, breast feeding, or intends to conceive a child during the
study.
4. Known allergy or hypersensitivity to any component of the investigational study
products (QM1114-DP or BOTOX®) or any other BoNT serotype.
5. Inability to substantially lessen GL by physically spreading them apart, as determined
by the Investigator.
6. Clinically significant abnormal lab finding(s) at screening, or clinically significant
abnormal focused physical exam finding(s) at screening or baseline visits, in the
opinion of the Investigator.
7. Excessive skin laxity in the treatment area or periorbital area.
8. Previous use of any hyaluronic acid soft tissue augmentation therapy in the glabella
or forehead area within 6 months before baseline.
9. Previous soft tissue augmentation with any permanent (non-biodegradable such as
silicone, polyacrylamide, etc.) or semi-permanent (i.e., calcium hydroxylapatite,
poly-L-Lactic acid or polymethyl-methacrylate) product; lifting threads, or autologous
fat in the treatment area.
10. History, presence, or predisposition of eyelid or eyebrow ptosis, amblyopia, or
previous surgery around the eye that may lead to the above events, as determined by
the Investigator.
11. Marked facial asymmetry, excessive dermatochalasis (i.e., excess of skin in eyelids),
or marked periocular or eyebrow asymmetry.
12. Presence of scar(s), piercing(s), or tattoo(s) (including microblading of eyebrow or
eyeliner) in the treatment area or around the treatment area that, in the
Investigator's opinion, may interfere with study evaluations.
13. Presence of inflammation, active infection or skin disorder such as eczema, rosacea,
facial psoriasis, herpes zoster etc., near or in the treatment area.
14. Presence of cancerous or pre-cancerous lesions in the treatment area.
15. History of other facial treatment, surgery or other aesthetic procedures (e.g.,
ablative skin resurfacing, laser treatment, micro needling, chemical peel) in the
previous 12 months that, in the Investigator's opinion, could interfere with study
injections and/or assessments.
16. Planned facial surgery, eye surgery (including LASIK procedure) or facial aesthetic
procedures (e.g., ablative skin resurfacing, laser treatment, micro needling, chemical
peel, BoNT treatment, or dermal fillers) in the face during the study period.
17. History or presence of facial nerve palsy, or any medical condition that may put the
subject at increased risk with exposure to BoNT including diagnosed myasthenia gravis,
Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that
might interfere with neuromuscular function.
18. Use of medications that affect neuromuscular transmission such as curare-like
depolarizing agents, lincosamides, polymyxins, anticholinesterases, and aminoglycoside
antibiotics.
19. Subject with bleeding disorder or subject currently using anticoagulants.
20. Subject has any prior or current psychiatric illness (e.g., Psychosis, depression,
anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or
antipsychotic medication that, in the Investigator's opinion, could affect the
subject's safety and/or participation in the study.
21. Other concurrent medical conditions, therapy, or other condition that, in the
Investigator's opinion, would interfere with the evaluation of the study medication,
safety or efficacy, and/or put the subject at risk if he/she participates in the
study.
22. Participation in an investigational device or drug study within 30 days prior to study
treatment or plans to enroll in any other investigational study during participation
in this study.
23. Study site personnel, close relatives of the study site personnel (e.g., parents,
children, siblings, or spouse), employees or close relatives of employees at the
Sponsor company.
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