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Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line

Efficacy and Safety of DWP450 Compared With Botox in Patients With Moderate to Severe Glabellar Line: Active Controlled, Double-blind, Randomized, Multi-center, Phase I/III Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01629875
Enrollment
268
Registered
2012-06-28
Start date
2012-03-31
Completion date
2012-11-30
Last updated
2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Glabellar Line

Brief summary

The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients.

Interventions

DRUGGeneric equivalent of Clostridium Botulinum A Toxin
DRUGBotox (Clostridium Botulinum A Toxin)

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Design outcomes

Primary

MeasureTime frameDescription
At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessmentAt 4 weeksAt 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment

Secondary

MeasureTime frameDescription
At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessmentAt 8, 12, 16 weeksAt 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026