NCT02303002

Brief Summary

This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

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

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

November 25, 2014

Last Update Submit

March 8, 2016

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown

    Week 24

  • Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity

    Up to Week 36

Study Arms (5)

Dose A

EXPERIMENTAL

Dose A: Botulinum Toxin Type A

Biological: Botulinum Toxin Type A

Dose B

EXPERIMENTAL

Dose B: Botulinum Toxin Type A

Biological: Botulinum Toxin Type A

Dose C

EXPERIMENTAL

Dose C: Botulinum Toxin Type A

Biological: Botulinum Toxin Type A

Dose D

ACTIVE COMPARATOR

Dose D: Botulinum Toxin Type A

Biological: Active Comparator botulinum toxin

Dose E

PLACEBO COMPARATOR

Dose E: Placebo

Biological: Placebo Comparator

Interventions

Botulinum Toxin Type ABIOLOGICAL

Intramuscular injection (IM)

Dose ADose BDose C
Active Comparator botulinum toxinBIOLOGICAL

IM injection

Dose D
Placebo ComparatorBIOLOGICAL

IM injection

Dose E

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate or severe glabellar frown lines
  • Female or male, 30 to 65 years of age in good general health
  • Women of childbearing potential must agree to use an effective method of birth control during the course of the study
  • Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

You may not qualify if:

  • Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
  • Muscle weakness or paralysis, particularly in the treatment area
  • Active skin disease or infections or irritation at the treatment area
  • Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
  • Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Vancouver, British Columbia, Canada

Location

Related Publications (2)

  • Bertucci V, Humphrey S, Carruthers J, Solish N, Muhn C, Swift A, Rubio RG, Shears G, Rosen N. Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364.

    PMID: 33065952DERIVED

  • Carruthers J, Solish N, Humphrey S, Rosen N, Muhn C, Bertucci V, Swift A, Metelitsa A, Rubio RG, Waugh J, Quiring J, Shears G, Carruthers A. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo. Dermatol Surg. 2017 Nov;43(11):1321-1331. doi: 10.1097/DSS.0000000000001206.

    PMID: 28614091DERIVED

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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

CA(1)