Botulinum Toxin A in the Treatment of Hemifacial Spasm

NCT ID: NCT03306940

Last Updated: 2017-10-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Hemifacial Spasm

Keywords

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botulinum toxin A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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unilateral injection group

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

Group Type PLACEBO_COMPARATOR

Botulinum Toxin Type A

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Chinese botulinum toxin type A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji University

OTHER

Sponsor Role lead

Responsible Party

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Lingjing Jin

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Lingjing Jin, PhD

Role: CONTACT

Phone: +86 02166111310

Email: [email protected]

Libin Xiao, MBA

Role: CONTACT

Phone: +86 13916266214

Email: [email protected]

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.

Reference Type RESULT
PMID: 12145388 (View on PubMed)

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.

Reference Type RESULT
PMID: 22092807 (View on PubMed)

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

Reference Type RESULT
PMID: 8122572 (View on PubMed)

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.

Reference Type RESULT
PMID: 27431279 (View on PubMed)

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.

Reference Type RESULT
PMID: 23444480 (View on PubMed)

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.

Reference Type RESULT
PMID: 1448532 (View on PubMed)

Other Identifiers

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14SG21

Identifier Type: -

Identifier Source: org_study_id