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Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

R

Region Västerbotten

Status

Completed

Conditions

Botulinum Toxins, Type A
Bite Force

Treatments

Drug: Botulinum toxin type A

Study type

Interventional

Funder types

Other

Identifiers

NCT05309564
BTX-Thailand

Details and patient eligibility

About

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).

Full 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.

Enrollment

32 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

Exclusion criteria

Conditions or drugs affecting the central nervous system.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Intervention
Experimental group
Description:
Intervention with single botulinum neurotoxin injection into masseter.
Treatment:
Drug: Botulinum toxin type A
Control
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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