NCT05309564

Brief Summary

This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

March 14, 2022

Last Update Submit

May 2, 2023

Conditions

Bite ForceBotulinum Toxins, Type A

Outcome Measures

Primary Outcomes (1)

  • Change of bite force

    Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline.

    Baseline, 4 weeks, 3 months, 6 months, 12 months.

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention with single botulinum neurotoxin injection into masseter.

Drug: Botulinum toxin type A

Control

NO INTERVENTION

No intervention

Interventions

Botulinum toxin type ADRUG

Single intervention

Also known as: Xeomin
Intervention

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

You may not qualify if:

  • Conditions or drugs affecting the central nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norrlands universitetssjukhus

Umeå, Västerbotten County, 90185, Sweden

Location

MeSH Terms

Interventions

Botulinum Toxins, Type AincobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • 2020-03517 Pettersson, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 4, 2022

Study Start

March 1, 2020

Primary Completion

January 10, 2022

Study Completion

March 14, 2022

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)