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

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ClinicalTrials.gov Identifier: NCT01629875
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 268 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arm Intervention/treatment
Experimental: DWP450 Drug: Generic equivalent of Clostridium Botulinum A Toxin
Active Comparator: Botox Drug: Botox (Clostridium Botulinum A Toxin)



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01629875     History of Changes
Other Study ID Numbers: DW_DWP450001
First Posted: June 28, 2012    Key Record Dates
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