Evaluate the Efficacy and Safety of DWP712 With Moderate to Severe Glabellar Lines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DWP712 inj., Botox® 100 Units.
- Who it may be relevant to
- Registry conditions: Glabellar Lines. Basic parameters: 19 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Double-blind, Randomized, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP712 Inj. in Subjects With Moderate to Severe Glabellar Lines
Overview
To evaluate the efficacy and safety of DWP712 Inj. in Subjects with Moderate to Severe Glabellar Lines
Interventions
- Biological DWP712 inj.
Clostridium botulinum Toxin - Biological Botox® 100 Units
Clostridium botulinum Toxin
Primary outcome measures
- 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 [Time frame: At 4 weeks after IP administration]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Chung-Ang University Hosptial — Seoul
Identifiers
NCT: NCT07013279 · DW_DWP712301