Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study)

June 8, 2017 updated by: Daewoong Pharmaceutical Co. LTD.

Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines: Multi-center, Single Arm, Open, Extension Study

The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 3

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female of at least 18 to 75 years old
  • moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
  • moderate-to-severe GL at maximum frawn on the FWS as rated by the investigator
  • Subject who has completed phase 3 study for CFL.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clostridium Botulinum A Toxin
Drug: Clostridium Botulinum A Toxin
Clostridium Botulinum A Toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Assessment of Satisfaction of Appearance
Time Frame: At 4 weeks
Subject Assessment of Satisfaction of Appearance
At 4 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 (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP450005E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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