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Clinical Trials/NCT01629875
NCT01629875CompletedPhase 3

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

Daewoong Pharmaceutical Co. LTD.1 site in 1 country268 target enrollmentStarted: March 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
268
Locations
1
Primary Endpoint
At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

DWP450

Experimental

Intervention: Generic equivalent of Clostridium Botulinum A Toxin (Drug)

Botox

Active Comparator

Intervention: Botox (Clostridium Botulinum A Toxin) (Drug)

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor
Daewoong Pharmaceutical Co. LTD.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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