NCT02882893

Brief Summary

The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows Feet Lines(CFL).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 25, 2016

Last Update Submit

August 29, 2016

Conditions

Crows Feet Lines

Outcome Measures

Primary Outcomes (1)

  • Facial Wrinkle Scale(FWS) severity of Crow's feet lines(CFL) at maximum smile as assessed by investigators

    At 4 weeks

Study Arms (2)

DWP450

EXPERIMENTAL

Single-dose

Drug: Clostridium Botulinum A Toxin

Botox

ACTIVE COMPARATOR

Single-dose

Drug: Clostridium Botulinum A Toxin

Interventions

Clostridium Botulinum A ToxinDRUG
Also known as: BOTOX
Botox

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
  • Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Daewoong Clinical

CONTACT

8225508800

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)