NCT02428608

Brief Summary

The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
570

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

April 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

April 21, 2015

Results QC Date

January 11, 2019

Last Update Submit

April 22, 2019

Conditions

Glabellar Frown Lines

Keywords

Glabellar LinesBotulinum toxin, Type A

Outcome Measures

Primary Outcomes (1)

  • The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year

    The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.

    365 days

Other Outcomes (1)

  • Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown

    365 days

Study Arms (1)

Botulinum toxin, Tyoe A

EXPERIMENTAL

DWP-450 (Botulinum toxin, Type A)

Biological: DWP-450 (Botulinum purified neurotoxin, Type A)

Interventions

DWP-450 (Botulinum purified neurotoxin, Type A)BIOLOGICAL

Botulinum toxin, Type A

Also known as: DWP-450
Botulinum toxin, Tyoe A

Eligibility Criteria

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

You may qualify if:

  • Subjects must be an adult 18 years of age and over
  • Subject is able to provide informed consent and comply with study instructions
  • Subject has moderate-to-severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS
  • Subject is willing and able to complete the entire course of the study

You may not qualify if:

  • Previous treatment with botulinum toxin of any serotype in any area within the last 6 months
  • Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
  • Previous insertion of permanent material in the glabellar area
  • Planned treatment with botulinum toxin of any serotype in any other body region during the study period
  • Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
  • Energy based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
  • Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
  • Inability to substantially lessen glabellar frown lines even by physically spreading them apart
  • Marked facial asymmetry
  • Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis
  • History of facial nerve palsy
  • Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
  • Any active infection in the area of the injection sites
  • Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
  • Evidence of recent alcohol or drug abuse
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Advanced Skin Research Center at Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

MeSH Terms

Interventions

DWP450

Results Point of Contact

Title
Rui L. Avelar, MD
Organization
Evolus, Inc
rui@evolusinc.com
(805)689-8668

Study Officials

  • Rui Avelar, MD

    Evolus, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
This is an open label safety study
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 29, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

April 24, 2019

Results First Posted

February 5, 2019

Record last verified: 2019-04

Locations

US(1)