Development of a method for the measuremnet of botulinumtoxin injection in the facial muscles

Single-blinded randomized trial of Botulinumtoxin A (Vistabel®) and its objective paralytic effect in the facial muscles of healthy women: development of new neurophysiological measurements. - Glabellar neurophysiology upon BoNT injection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004636-66-SE

Enrollment

Registered

2011-10-06

Start date

2011-12-05

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The treatment of glabellar lines in healthy women by muscle paralysis from injection of botulinum toxin

Interventions

Trade Name: VISTABEL Pharmaceutical Form: Solution for injection CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: U unit(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy women in the age of 30-64 years of age (not yet 65 years). Visible glabellar lines. Motivated to participate in the clinical trial without any economical compensation. Filled in the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Clinical or subclinical neuromuscular disorder/symptoms. Allergy towards the BoNT which will be used or other component. Previous injections of BoNT or plastic surgery in the facial region. Implants in the glabellar region. Ongoing infection, systemic disease or inflammation around the muscles to be injected. Earlier unspecified severe allergic reactions. Known coagulation deficit or anticoagulantia. Medication with anticholinergic or muscle relaxing agents. Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Main Objective: The reduction of the muscle response (muscle paralysis) by motor nerve stimulation (“CMAP”) from the facial muscles correlates with the given dose botulinum toxin (Vistabel in Allergan units) injected in the muscle.;Secondary Objective: The distance effect to other facial muscles by botulinum toxin injection in the glabellar muscles is a good measure of the ”safety” of injection and correlates to the given botulinum toxin dose. ;Primary end point(s): Course of muscle paralysis, denervation and reinnervation from BoNT injection in facial muscles. ;Timepoint(s) of evaluation of this end point: Time points include: 1) Before BoNT injection (baseline) 2) 2 weeks following BoNT 3) 4 weeks following BoNT 4) 12 weeks following BoNT 5) 24 weeks following BoNT	—

Measure

Time frame

Main Objective: The reduction of the muscle response (muscle paralysis) by motor nerve stimulation (“CMAP”) from the facial muscles correlates with the given dose botulinum toxin (Vistabel in Allergan units) injected in the muscle.;Secondary Objective: The distance effect to other facial muscles by botulinum toxin injection in the glabellar muscles is a good measure of the ”safety” of injection and correlates to the given botulinum toxin dose. ;Primary end point(s): Course of muscle paralysis, denervation and reinnervation from BoNT injection in facial muscles. ;Timepoint(s) of evaluation of this end point: Time points include: 1) Before BoNT injection (baseline) 2) 2 weeks following BoNT 3) 4 weeks following BoNT 4) 12 weeks following BoNT 5) 24 weeks following BoNT

—

Secondary

Measure	Time frame
Secondary end point(s): Course of distance effects to surrounding facial muscles (eye muscles) following glabellar BoNT injection.;Timepoint(s) of evaluation of this end point: Time points include: 1) Before BoNT injection (baseline) 2) 2 weeks following BoNT 3) 4 weeks following BoNT 4) 12 weeks following BoNT 5) 24 weeks following BoNT	—

Countries

Sweden

Contacts

Public ContactDepartment of Clinical Neurophysiol

Uppsala University Hospital

sekretariat.neurofys@akademiska.se+46186113441

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026