Evaluate the Efficacy and Safety of DWP712 With Moderate to Severe Glabellar Lines
Phase 3
Not yet recruiting
- Conditions
- Glabellar Lines
- Interventions
- Biological: DWP712 inj.Biological: Botox® 100 Units
- Registration Number
- NCT07013279
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
To evaluate the efficacy and safety of DWP712 Inj. in Subjects with Moderate to Severe Glabellar Lines
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 324
Inclusion Criteria
- Subjects with a facial wrinkle scale (FWS) score of ≥2 (moderate) for glabellar lines at maximum frown in the investigator's on-site assessment at screening
Exclusion Criteria
- Subjects with glabellar lines that cannot sufficiently be improved by physical attempts, e.g., glabellar lines not flattened by hand, in the judgment of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DWP712 inj. DWP712 inj. The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL. Botox® 100 Units Botox® 100 Units The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL.
- Primary Outcome Measures
Name Time Method Percentage of subjects with glabellar line improvement* rate at maximum frown based on the investigator's on-site assessment at 4 weeks after IP administration At 4 weeks after IP administration Improvement means FWS grade of "0" or "1" with a ≥2-point improvement from baseline
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does DWP712 utilize to reduce glabellar lines compared to Botox®?
How does the efficacy of DWP712 compare to standard-of-care botulinum toxin treatments for moderate to severe glabellar lines?
Are there specific biomarkers that can predict patient response to DWP712 in facial wrinkle treatment?
What are the potential adverse events associated with DWP712 injections and how are they managed?
What are the key differences in safety profiles between DWP712 and competitor botulinum toxin drugs in Phase III trials?
Trial Locations
- Locations (1)
Chung-Ang University Hosptial
🇰🇷Seoul, Korea, Republic of