Botulinum Toxin A in the Treatment of Hemifacial Spasm (BTATHS)

T

Tongji University

Status

Unknown

Conditions

Hemifacial Spasm

Treatments

Drug: Botulinum Toxin Type A

Study type

Interventional

Funder types

Other

Identifiers

NCT03306940
14SG21

Details and patient eligibility

About

Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups. Group A received unilateral injection while group B received bilateral injection. Patients completed follow-up A researcher record facial videos and analyzed facial symmetry and completed 3 scales.

Full description

Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups.Patients of unilateral group were injected to the affected side and the dose of botulinum toxin A was 2.5-3.75 units/per site. Patients of bilateral group were injected to the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with dose of 1.25 units/per site. 3 scales for measurement were used.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • clinical diagnosis of hemifacial spasm
  • Scott grading III to IV
  • hemifacial spasm duration of half or more years
  • last botulinum toxin A application at least 3 months before the start of the study

Exclusion criteria

  • history of facial trauma, congenital facial asymmetry, facial nerve microsurgical decompression
  • bilateral hemifacial spasm
  • allergies to botulinum toxin A or to any component of the drug
  • previous treatment with botulinum toxin A fewer than 3 months
  • the use of drugs that could interfere with neuromuscular transmission or spasm

Trial design

50 participants in 2 patient groups, including a placebo group

unilateral injection group
Placebo Comparator group
Description:
Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
Treatment:
Drug: Botulinum Toxin Type A
bilateral injection group
Experimental group
Description:
Patients of bilateral group were injected botulinum toxin type A to the affected hemiface and normal hemiface. The intervention of the bilateral group was that the normal side was injected.
Treatment:
Drug: Botulinum Toxin Type A

Trial contacts and locations

0

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Central trial contact

Lingjing Jin, PhD; Libin Xiao, MBA

Data sourced from clinicaltrials.gov

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