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Efficacy of isolated periocular botulinum toxin A injections versus periocular and adjective lower facial injunctions in hemifacial spasm: a randomized, controlled, noninferiority, crossover trial

Efficacy of isolated periocular botulinum toxin A injections versus periocular and adjective lower facial injunctions in hemifacial spasm: a randomized, controlled, noninferiority, crossover trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220916002
Enrollment
46
Registered
2022-09-16
Start date
2022-12-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemifacial spasm hemifacial spasm botulinum toxin

Interventions

Botulinum toxin administration for periocular muscle Normal saline administration for peri-oral muscle ,Botulinum toxin administration for periocular muscle and peri-oral muscle
Experimental Drug,Active Comparator Drug

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.No BoNT-A injections had been given to the face during the preceding 4 months (the BoNT-A washout period).5,15,16 2.There were no other augmentation treatments for HFS, such as oral medications (benzodiazepines, gabapentin, or baclofen). 3.The patients were between 18 and 85 years of age (to ensure cognitive ability for subjective assessments).

Exclusion criteria

Exclusion criteria: 1.Patients unresponsive to BoNT-A (suspected BoNT-A immunogenic cases) 2.Pregnant or lactating women 3.Individuals with a history of serious side effects or known allergies to BoNT-A 4.Patients with muscle weakness disorders, such as myasthenia gravis

Design outcomes

Primary

MeasureTime frame
control clinical of hemifacial spasm at 1 month Self reported of disease severity by visual analogue scale (VAS)

Secondary

MeasureTime frame
quality of life Preinjection & at 1 month HFS-30 Thai version,severity grading of HFS preinjection & 1 month Samsung medical center grading system (SMC grade),severity grading of HFS preinjection & 1 month The Hemifacial Spasm Grading Scale

Countries

Thailand

Contacts

Public ContactAkarawit Eiamsamarng

Faculty of Medicine Siriraj Hospital, Mahidol University

cokejoon13@gmail.com0929299259

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026