<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03306940</url>
  </required_header>
  <id_info>
    <org_study_id>14SG21</org_study_id>
    <nct_id>NCT03306940</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin A in the Treatment of Hemifacial Spasm</brief_title>
  <acronym>BTATHS</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemifacial spasm patients who received botulinum toxin A injection were divided into two&#xD;
      groups. Group A received unilateral injection while group B received bilateral injection.&#xD;
      Patients completed follow-up A researcher record facial videos and analyzed facial symmetry&#xD;
      and completed 3 scales.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemifacial spasm patients who received botulinum toxin A injection were divided into two&#xD;
      groups.Patients of unilateral group were injected to the affected side and the dose of&#xD;
      botulinum toxin A was 2.5-3.75 units/per site. Patients of bilateral group were injected to&#xD;
      the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with&#xD;
      dose of 1.25 units/per site.&#xD;
&#xD;
      3 scales for measurement were used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sunnybrook Facial Grading System</measure>
    <time_frame>up to 6 months</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symmetry Scale for Hemifacial Spasm</measure>
    <time_frame>up to 6 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facial Clinimetric Evaluation Scale</measure>
    <time_frame>up to 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effective duration of botulinum toxin A</measure>
    <time_frame>up to 6 months</time_frame>
    <description>degree of amelioration in spasm and the effective duration of botulinum toxin A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 6 months</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hemifacial Spasm</condition>
  <arm_group>
    <arm_group_label>unilateral injection group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bilateral injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Type A</intervention_name>
    <description>patients were injected to the normal side with dose of 1.25 units/per site</description>
    <arm_group_label>bilateral injection group</arm_group_label>
    <arm_group_label>unilateral injection group</arm_group_label>
    <other_name>Chinese botulinum toxin type A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of hemifacial spasm&#xD;
&#xD;
          -  Scott grading III to IV&#xD;
&#xD;
          -  hemifacial spasm duration of half or more years&#xD;
&#xD;
          -  last botulinum toxin A application at least 3 months before the start of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of facial trauma, congenital facial asymmetry, facial nerve microsurgical&#xD;
             decompression&#xD;
&#xD;
          -  bilateral hemifacial spasm&#xD;
&#xD;
          -  allergies to botulinum toxin A or to any component of the drug&#xD;
&#xD;
          -  previous treatment with botulinum toxin A fewer than 3 months&#xD;
&#xD;
          -  the use of drugs that could interfere with neuromuscular transmission or spasm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lingjing Jin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Tongji Hospital, Tongji University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lingjing Jin, PhD</last_name>
    <phone>+86 02166111310</phone>
    <email>1164427300@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Libin Xiao, MBA</last_name>
    <phone>+86 13916266214</phone>
    <email>xiaolibinjiayou@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lingjing Jin, PhD</last_name>
      <phone>+86 02166111310</phone>
      <email>1164427300@qq.com</email>
    </contact>
    <contact_backup>
      <last_name>Libin Xiao, MBA</last_name>
      <phone>+86 13916266214</phone>
      <email>xiaolibinjiayou@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>12145388</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>22092807</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>8122572</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>27431279</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>23444480</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>1448532</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji University</investigator_affiliation>
    <investigator_full_name>Lingjing Jin</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>botulinum toxin A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Hemifacial Spasm</mesh_term>
    <mesh_term>Spasm</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306940
org study id: 14SG21
nct id: NCT03306940
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Sunnybrook Facial Grading System
time frame: up to 6 months
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
measure: Symmetry Scale for Hemifacial Spasm
time frame: up to 6 months
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
measure: Facial Clinimetric Evaluation Scale
time frame: up to 6 months
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.
measure: The effective duration of botulinum toxin A
time frame: up to 6 months
description: degree of amelioration in spasm and the effective duration of botulinum toxin A
measure: Adverse events
time frame: up to 6 months
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
arm group label: unilateral injection group
arm group type: Placebo Comparator
description: Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
arm group label: bilateral injection group
arm group type: Experimental
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: Botulinum Toxin Type A
description: patients were injected to the normal side with dose of 1.25 units/per site
arm group label: bilateral injection group
arm group label: unilateral injection group
other name: Chinese botulinum toxin type A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lingjing Jin, PhD
role: Principal Investigator
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
last name: Lingjing Jin, PhD
phone: +86 02166111310
email: 1164427300@qq.com
last name: Libin Xiao, MBA
phone: +86 13916266214
email: xiaolibinjiayou@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
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.
PMID: 12145388
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.
PMID: 22092807
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.
PMID: 8122572
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.
PMID: 27431279
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.
PMID: 23444480
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.
PMID: 1448532
responsible party type: Principal Investigator
investigator affiliation: Tongji University
investigator full name: Lingjing Jin
investigator title: professor
mesh term: Muscle Cramp
mesh term: Hemifacial Spasm
mesh term: Spasm
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: Undecided