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Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

Sponsor
Region Västerbotten (Other)
Overall Status
Completed
CT.gov ID
NCT05309564
Collaborator
Umeå University (Other), Mahidol University (Other)
32
Enrollment
1
Location
2
Arms
24.4
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin type A
 N/A

Detailed Description

This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF) 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). A control group did not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the incisors and first molars. The intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Mar 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Intervention with single botulinum neurotoxin injection into masseter.

Drug: Botulinum toxin type A
Single intervention
Other Names:
  • Xeomin

    		•
    No Intervention: Control

    No intervention

    Outcome Measures

    Primary Outcome Measures

    1. Change of bite force [Baseline, 4 weeks, 3 months, 6 months, 12 months.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

    Exclusion Criteria:

    Conditions or drugs affecting the central nervous system.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Norrlands universitetssjukhus Umeå Västerbotten Sweden 90185

    Sponsors and Collaborators

    • Region Västerbotten
    • Umeå University
    • Mahidol University

    Investigators

    • Principal Investigator: 2020-03517 Pettersson, PhD, Umeå University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Region Västerbotten
    ClinicalTrials.gov Identifier:
    NCT05309564
    Other Study ID Numbers:
    • BTX-Thailand
    First Posted:
    Apr 4, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Muscle Weakness
    Paresis
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Apr 7, 2022