Botulinum Toxin A in the Treatment of Hemifacial Spasm (BTATHS)
Primary Purpose
Hemifacial Spasm
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Hemifacial Spasm focused on measuring botulinum toxin A
Eligibility Criteria
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
Sites / Locations
- Shanghai Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
unilateral injection group
bilateral injection group
Arm Description
Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
The effective duration of botulinum toxin A
degree of amelioration in spasm and the effective duration of botulinum toxin A
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03306940
Brief Title
Botulinum Toxin A in the Treatment of Hemifacial Spasm
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
August 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemifacial Spasm
Keywords
botulinum toxin A
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
unilateral injection group
Arm Type
Placebo Comparator
Arm Description
Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
Arm Title
bilateral injection group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Chinese botulinum toxin type A
Intervention Description
patients were injected to the normal side with dose of 1.25 units/per site
Primary Outcome Measure Information:
Title
Sunnybrook Facial Grading System
Description
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
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Symmetry Scale for Hemifacial Spasm
Description
Symmetry Scale for Hemifacial Spasm consists of resting symmetry and symmetry of voluntary movement. Total score =Resting symmetry score + Symmetry of voluntary movement score
Time Frame
up to 6 months
Title
Facial Clinimetric Evaluation Scale
Description
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.
Time Frame
up to 6 months
Title
The effective duration of botulinum toxin A
Description
degree of amelioration in spasm and the effective duration of botulinum toxin A
Time Frame
up to 6 months
Title
Adverse events
Description
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
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingjing Jin, PhD
Phone
+86 02166111310
Email
1164427300@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Libin Xiao, MBA
Phone
+86 13916266214
Email
xiaolibinjiayou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lingjing Jin, PhD
Organizational Affiliation
Shanghai Tongji Hospital, Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingjing Jin, PhD
Phone
+86 02166111310
Email
1164427300@qq.com
First Name & Middle Initial & Last Name & Degree
Libin Xiao, MBA
Phone
+86 13916266214
Email
xiaolibinjiayou@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12145388
Citation
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.
Results Reference
result
PubMed Identifier
22092807
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.
Results Reference
result
PubMed Identifier
8122572
Citation
Isse NG. Endoscopic facial rejuvenation: endoforehead, the functional lift. Case reports. Aesthetic Plast Surg. 1994 Winter;18(1):21-9. doi: 10.1007/BF00444243.
Results Reference
result
PubMed Identifier
27431279
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. doi: 10.1007/s10072-016-2670-2. Epub 2016 Jul 18.
Results Reference
result
PubMed Identifier
23444480
Citation
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.
Results Reference
result
PubMed Identifier
1448532
Citation
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.
Results Reference
result
Learn more about this trial
Botulinum Toxin A in the Treatment of Hemifacial Spasm
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