Hemifacial SpasmBTATHSNCT03306940
Botulinum Toxin A in the Treatment of Hemifacial Spasm
A study testing Botulinum Toxin Type A in people with Hemifacial Spasm, run by Tongji University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemifacial Spasm
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 2 Oct 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Lingjing Jin, PhD, +86 02166111310, 1164427300@qq.com
Libin Xiao, MBA, +86 13916266214, xiaolibinjiayou@163.com
About this study
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
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.
Read the 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.
- Conditions
- Hemifacial Spasm
- Being tested
- Botulinum Toxin Type A
- Keywords
- botulinum toxin A
- Medical subject headings
- Hemifacial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Chinese botulinum toxin type A
patients were injected to the normal side with dose of 1.25 units/per site
| Study group | Role | What they receive |
|---|---|---|
| unilateral injection group | Placebo comparator | Patients of unilateral group were injected botulinum toxin type A to the affected hemiface. Receives: 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. Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Secondary outcomes (4)
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
Measured: up to 6 months
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.
Measured: up to 6 months
The effective duration of botulinum toxin A
degree of amelioration in spasm and the effective duration of botulinum toxin A
Measured: up to 6 months
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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start2 Oct 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemifacial SpasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingjing Jin, Tongji University
- Investigators
- Lingjing Jin, PhD, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306940
- Sponsor's protocol ID
- 14SG21
- Acronym
- BTATHS
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12145388Fujimura 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.
PubMed 22092807Isse NG. Endoscopic facial rejuvenation: endoforehead, the functional lift. Case reports. Aesthetic Plast Surg. 1994 Winter;18(1):21-9. doi: 10.1007/BF00444243.
PubMed 8122572Xiao 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.
PubMed 27431279Kim 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.
PubMed 23444480Borodic 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.
PubMed 1448532
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03306940
- Acronym / sponsor ID
- BTATHS / 14SG21
- Conditions
- Hemifacial Spasm
- Keywords
- botulinum toxin A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral injection group | Placebo comparator | Drug: Botulinum Toxin Type APatients of unilateral group were injected botulinum toxin type A to the affected hemiface. |
| bilateral injection group | Experimental | Drug: Botulinum Toxin Type APatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: Chinese botulinum toxin type Apatients were injected to the normal side with dose of 1.25 units/per site | Drug | bilateral injection group, unilateral injection group |
Primary outcome
Sunnybrook Facial Grading System
Time frame: 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
4 secondary outcomes
Symmetry Scale for Hemifacial Spasm
Time frame: up to 6 months
Facial Clinimetric Evaluation Scale
Time frame: up to 6 months
The effective duration of botulinum toxin A
Time frame: up to 6 months
Adverse events
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Results publication: PubMed 12145388Tan 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 publication: PubMed 22092807Fujimura 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 publication: PubMed 8122572Isse NG. Endoscopic facial rejuvenation: endoforehead, the functional lift. Case reports. Aesthetic Plast Surg. 1994 Winter;18(1):21-9. doi: 10.1007/BF00444243.
- Results publication: PubMed 27431279Xiao 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 publication: PubMed 23444480Kim 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 publication: PubMed 1448532Borodic 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hemifacial Spasm
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
Not yet recruitingObservational study
Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict
Trigeminal Neuralgia, Tic Douloureux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingjing Jin, PhD principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A in people with Hemifacial Spasm, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingjing Jin, PhD (+86 02166111310, 1164427300@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunnybrook Facial Grading System (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306940, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.