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

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

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