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

Phase 1

• Conditions: The treatment of glabellar lines in healthy women by muscle paralysis from injection of botulinum toxin; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2011-004636-66-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-06
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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