Botulinum Toxin A in the Treatment of Hemifacial Spasm

NCT03306940 | Unknown DMC

• 1 other identifier: 14SG21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemifacial Spasm

Keywords

botulinum toxin A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Symmetry Scale for Hemifacial Spasm

  up to 6 months

• Facial Clinimetric Evaluation Scale

  up to 6 months

• The effective duration of botulinum toxin A

  up to 6 months

• Adverse events

  up to 6 months

Study Arms (2)

unilateral injection group

PLACEBO COMPARATOR

Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.

Drug: Botulinum Toxin Type A

bilateral injection group

EXPERIMENTAL

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.

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

patients were injected to the normal side with dose of 1.25 units/per site

Also known as: Chinese botulinum toxin type A

bilateral injection group; unilateral injection group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

Related Publications (6)

• Tan NC, Chan LL, Tan EK. Hemifacial spasm and involuntary facial movements. QJM. 2002 Aug;95(8):493-500. doi: 10.1093/qjmed/95.8.493.

  PMID: 12145388 RESULT

• 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.

  PMID: 22092807 RESULT

• Isse NG. Endoscopic facial rejuvenation: endoforehead, the functional lift. Case reports. Aesthetic Plast Surg. 1994 Winter;18(1):21-9. doi: 10.1007/BF00444243.

  PMID: 8122572 RESULT

• 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. doi: 10.1007/s10072-016-2670-2. Epub 2016 Jul 18.

  PMID: 27431279 RESULT

• Kim J. Contralateral botulinum toxin injection to improve facial asymmetry after acute facial paralysis. Otol Neurotol. 2013 Feb;34(2):319-24. doi: 10.1097/mao.0b013e31827c9f58.

  PMID: 23444480 RESULT

• 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.

  PMID: 1448532 RESULT

MeSH Terms

Conditions

Hemifacial Spasm

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Lingjing Jin, PhD

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingjing Jin, PhD

CONTACT

+86 02166111310; 1164427300@qq.com

Libin Xiao, MBA

CONTACT

+86 13916266214; xiaolibinjiayou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 11, 2017
• Study Start: October 2, 2017
• Primary Completion: July 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

CN (1)