NCT03184363

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

June 8, 2017

Last Update Submit

June 8, 2017

Conditions

Crow's Feet LinesGlabellar Lines

Outcome Measures

Primary Outcomes (1)

  • Subject Assessment of Satisfaction of Appearance

    Subject Assessment of Satisfaction of Appearance

    At 4 weeks

Study Arms (1)

Clostridium Botulinum A Toxin

EXPERIMENTAL

Clostridium Botulinum A Toxin

Drug: Clostridium Botulinum A Toxin

Interventions

Clostridium Botulinum A ToxinDRUG

Clostridium Botulinum A Toxin

Clostridium Botulinum A Toxin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 12, 2017

Study Start

July 1, 2017

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06