Botulinum Toxin A in the Treatment of Hemifacial Spasm

Hemifacial Spasm Clinical Trial

— BTATHS  

Official title:

Does Bilateral Botulinum Toxin A in Patients With Hemifacial Spasm Improve Facial Symmetry Unilateral and Bilateral Injection of Botulinum Toxin A in Patients With Hemifacial Spasm? A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306940
• Other study ID #: 14SG21
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 11, 2017
• Start date: October 2, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2017
• Source: Tongji University
• Contact: Lingjing Jin, PhD
• Phone: +86 02166111310
• Email: 1164427300[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemifacial Spasm
• Muscle Cramp
• Spasm

Intervention

Drug:
• Botulinum Toxin Type A
patients were injected to the normal side with dose of 1.25 units/per site

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

References & Publications (6)

Borodic GE, Cheney M, McKenna M. Contralateral injections of botulinum A toxin for the treatment of hemifacial spasm to achieve increased facial symmetry. Plast Reconstr Surg. 1992 Dec;90(6):972-7; discussion 978-9. — View Citation

Fujimura T, Hotta M. The preliminary study of the relationship between facial movements and wrinkle formation. Skin Res Technol. 2012 May;18(2):219-24. doi: 10.1111/j.1600-0846.2011.00557.x. Epub 2011 Aug 25. — View Citation

Isse NG. Endoscopic facial rejuvenation: endoforehead, the functional lift. Case reports. Aesthetic Plast Surg. 1994 Winter;18(1):21-9. — View Citation

Kim J. Contralateral botulinum toxin injection to improve facial asymmetry after acute facial paralysis. Otol Neurotol. 2013 Feb;34(2):319-24. — View Citation

Tan NC, Chan LL, Tan EK. Hemifacial spasm and involuntary facial movements. QJM. 2002 Aug;95(8):493-500. Review. — View Citation

Xiao L, Pan Y, Zhang X, Hu Y, Cai L, Nie Z, Pan L, Li B, He Y, Jin L. Facial asymmetry in patients with hemifacial spasm before and after botulinum toxin A treatment. Neurol Sci. 2016 Nov;37(11):1807-1813. Epub 2016 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sunnybrook Facial Grading System	Sunnybrook Facial Grading System consists of resting symmetry, symmetry of voluntary movement and synkinesis. Total score = Symmetry of voluntary movement score - Resting symmetry score - Synkinesis score	up to 6 months
Secondary	Symmetry Scale for Hemifacial Spasm	Symmetry Scale for Hemifacial Spasm consists of resting symmetry and symmetry of voluntary movement. Total score =Resting symmetry score + Symmetry of voluntary movement score	up to 6 months
Secondary	Facial Clinimetric Evaluation Scale	Facial Clinimetric Evaluation Scale consists of six parts:facial movement,facial comfort,oral function,eye comfort,lacrimal control and social function. Total score = facial movement + facial comfort + oral function + eye comfort + lacrimal control + social function.	up to 6 months
Secondary	The effective duration of botulinum toxin A	degree of amelioration in spasm and the effective duration of botulinum toxin A	up to 6 months
Secondary	Adverse events	Adverse events, including stiff face, difficulty drinking and eating, difficulty controlling parotid and so on.The onset and duration of adverse events.Whether to take intervention to ameliorate adverse events and the efficacy of the intervention	up to 6 months