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OpenTrials
Completed

NCT Number: NCT01629875

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

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

Completed

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Key information

Conditions

Moderate to Severe Glabellar Line

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treatment and study plan

Generic equivalent of Clostridium Botulinum A Toxin

Drug

Botox (Clostridium Botulinum A Toxin)

Drug

Primary outcomes

  1. At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment

    Time frame: At 4 weeks

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

Secondary outcomes

  1. At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment

    Time frame: At 8, 12, 16 weeks

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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2012
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.