Moderate to Severe Glabellar Lines
Conditions
Brief summary
A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines
Interventions
DRUGDWP450
The test drug or control drug is injected on the day of administration.
DRUGBotox®
The test drug or control drug is injected on the day of administration.
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult males or females aged 20-65 years old. * Moderate to severe (grade 2-3) glabellar lines based on investigator's assessment of severity of glabellar lines at maximum frown.
Exclusion criteria
* Having received any glabellar (including forehead) cosmetic procedures/surgeries, such as dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, or dermabrasion within 6 months prior to screening. * Planning to receive any facial cosmetic procedures/surgeries, including but not limited dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, during the study period. * Skin infection at injection site or systemic skin disease assessed with the potential to interfere with efficacy evaluation or safety evaluation of glabellar lines or forehead lines. * Glabellar lines that cannot be fully flattened through surgery, by hand or by other methods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown | Week 4 | The difference between the two groups in response rate at Week 4 based on the investigator's on-site assessment of severity of glabellar lines (at maximum frown). |
Countries
China
Outcome results
None listed