Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

Botulinum Toxins, Type A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309564
• Other study ID #: BTX-Thailand
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 14, 2022

Study information

• Verified date: May 2023
• Source: Region Västerbotten
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 14, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume. Exclusion Criteria: Conditions or drugs affecting the central nervous system.

Related Conditions & MeSH terms

• Bite Force
• Botulinum Toxins, Type A
• Muscle Weakness
• Paresis

Intervention

Drug:
• Botulinum toxin type A
Single intervention

Locations

Country	Name	City	State
Sweden	Norrlands universitetssjukhus	Umeå	Västerbotten

Sponsors (3)

Lead Sponsor	Collaborator
Region Västerbotten	Mahidol University, Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.