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

November 5, 2012 updated by: Daewoong Pharmaceutical Co. LTD.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

268

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DWP450
Drug: Generic equivalent of Clostridium Botulinum A Toxin
ACTIVE_COMPARATOR: Botox
Drug: Botox (Clostridium Botulinum A Toxin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 8, 12, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (ESTIMATE)

June 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP450001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Moderate to Severe Glabellar Line

Clinical Trials on Generic equivalent of Clostridium Botulinum A Toxin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe