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
Verified date | May 2023 |
Source | Region Västerbotten |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Norrlands universitetssjukhus | Umeå | Västerbotten |
Lead Sponsor | Collaborator |
---|---|
Region Västerbotten | Mahidol University, Umeå University |
Sweden,
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. |
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