Glabellar Frown Lines
Conditions
Brief summary
To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of moderate to severe glabellar lines.
Interventions
DRUGCunox
Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
DRUGBotox
Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged between 18 and 65 * Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum forced frown * Subjects who voluntarily sign the informed consent
Exclusion criteria
* Subjects with allergy or hypersensitivity to the investigational drugs or their components * Subjects who are participating in other clinical trials or have participated in clinical trials 30 days before screening * Subjects who are not eligible for this study at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity | at 4 weeks after the injection. | An investigator makes a live assessment of subject's glabellar lines at maximum frown on a 4-grade scale (0 (none), 1 (mild), 2 (moderate) and 3 (severe)) 4 weeks after the administration of the investigational drug or the comparator. 0 or 1 point is considered as improved and glabellar line improvement rate is calculated. |
Countries
Russia
Outcome results
None listed