Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2017-10-02
2018-08-31
Brief Summary
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Detailed Description
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3 scales for measurement were used.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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unilateral injection group
Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
Botulinum Toxin Type A
patients were injected to the normal side with dose of 1.25 units/per site
bilateral injection group
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.
Botulinum Toxin Type A
patients were injected to the normal side with dose of 1.25 units/per site
Interventions
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Botulinum Toxin Type A
patients were injected to the normal side with dose of 1.25 units/per site
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Tongji University
OTHER
Responsible Party
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Lingjing Jin
professor
Principal Investigators
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Lingjing Jin, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Tongji Hospital, Tongji University School of Medicine
Locations
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Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Lingjing Jin, PhD
Role: primary
Libin Xiao, MBA
Role: backup
References
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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.
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.
Isse NG. Endoscopic facial rejuvenation: endoforehead, the functional lift. Case reports. Aesthetic Plast Surg. 1994 Winter;18(1):21-9. doi: 10.1007/BF00444243.
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.
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.
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.
Other Identifiers
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14SG21
Identifier Type: -
Identifier Source: org_study_id