NCT03216408

Brief Summary

This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with moderate to severe glabellar lines.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
504

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

March 30, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

July 12, 2017

Last Update Submit

July 12, 2017

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

  • 4-grade scale by live assessment of glabellar line severity

    Glabellar line improvement rate at maximum frown

    4 weeks after injection

Study Arms (2)

Neuronox

EXPERIMENTAL

Botulinum toxin type A for Injection

Drug: Neuronox

Botox

ACTIVE COMPARATOR

Botulinum toxin type A for Injection

Drug: Botox

Interventions

NeuronoxDRUG
Also known as: Clostridium Botulinum Toxin A 100 U
Neuronox
BotoxDRUG
Also known as: Clostridium Botulinum Toxin A 50 U
Botox

Eligibility Criteria

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

You may qualify if:

  • Subjects aged between 18 and 65
  • Subjects with more than grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown

You may not qualify if:

  • Subjects with medical conditions who may be greater risk due to the administration of the investigational drugs
  • Subjects with skin disorders at the injection site

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 13, 2017

Study Start

March 30, 2016

Primary Completion

November 10, 2016

Study Completion

March 7, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07