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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629875
First Posted: June 28, 2012
Last Update Posted: November 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
  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
Masking: Double (Participant, 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:


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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629875


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

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01629875     History of Changes
Other Study ID Numbers: DW_DWP450001
First Submitted: June 26, 2012
First Posted: June 28, 2012
Last Update Posted: November 7, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents


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