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
| Registry | NCT03306940, acronym BTATHS |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 50 (Estimated) |
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| Sponsor | Tongji University (Other) |
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| Conditions | Hemifacial Spasm |
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| Interventions | Botulinum Toxin Type A (Drug) |
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| Dates | start 2017-10-02, primary completion 2018-07-31 (estimated), completion 2018-08-31 (estimated), first posted 2017-10-11, last updated 2017-10-12 |
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| Locations | 1 site in China |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| unilateral injection group | Placebo comparator | Drug: Botulinum Toxin Type A | Patients of unilateral group were injected botulinum toxin type A to the affected hemiface. |
| bilateral injection group | Experimental | Drug: Botulinum Toxin Type A | 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 (Drug), also known as Chinese botulinum toxin type A: patients were injected to the normal side with dose of 1.25 units/per site
+Outcome measures
Primary outcomes
- Sunnybrook Facial Grading System [up to 6 months]: 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 outcomes
- Symmetry Scale for Hemifacial Spasm [up to 6 months]: 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 [up to 6 months]: 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 [up to 6 months]: degree of amelioration in spasm and the effective duration of botulinum toxin A
- Adverse events [up to 6 months]: 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
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Shanghai Tongji Hospital | Shanghai, Shanghai Municipality | China | Recruiting |
+Publications
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
+Investigators
- Lingjing Jin, PhD, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine