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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01629875
First received: June 26, 2012
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Moderate to Severe Glabellar Line
 Drug: Generic equivalent of Clostridium Botulinum A Toxin
Drug: Botox (Clostridium Botulinum A Toxin)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment [ Time Frame: At 4 weeks ] [ Designated as safety issue: No ]
    At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment


Estimated Enrollment: 268
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DWP450 Drug: Generic equivalent of Clostridium Botulinum A Toxin
Active Comparator: Botox Drug: Botox (Clostridium Botulinum A Toxin)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629875

Locations
Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01629875     History of Changes
Other Study ID Numbers: DW_DWP450001
Study First Received: June 26, 2012
Last Updated: November 5, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013