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Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm

Primary Purpose

Hemifacial Spasm

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
preseptal injection of botulinum toxin type A
pretarsal injection of Botulinum toxin type A
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemifacial Spasm focused on measuring botulinum toxin, facial nerve, hemifacial spasm, tears

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient diagnosed with hemifacial spasm

Exclusion Criteria:

  • previous history of botulinum toxin treatment for hemifacial spasm
  • ocular surface disorders
  • tear disorders
  • evidence of infection at or around eyelids
  • pregnant woman
  • other neurologic disease, i.e. OMG
  • coagulopathy or treatment with thrombolytic agent
  • treatment with aminoglycosides, chloroquine, hydroxychloroquine

Sites / Locations

  • Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

preseptal

pretarsal

Arm Description

Outcomes

Primary Outcome Measures

tear break up time
unit of measure; minutes

Secondary Outcome Measures

schirmer's test
units of measurement; millimeters

Full Information

First Posted
March 18, 2012
Last Updated
March 27, 2012
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT01564979
Brief Title
Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
Official Title
Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.
Detailed Description
Botulinum toxin type A has been used for hemifacial spasm since 1986. of Botulinum toxin type A can be subcutaneously injected at pretarsal or preseptal portion of orbicularis muscle. Blepharoptosis has been reported less frequently with pretarsal technique, however dry eye was noticed in one patient treated with pretarsal botulinum toxin type A for cosmetic purpose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemifacial Spasm
Keywords
botulinum toxin, facial nerve, hemifacial spasm, tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preseptal
Arm Type
Experimental
Arm Title
pretarsal
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
preseptal injection of botulinum toxin type A
Other Intervention Name(s)
Botox
Intervention Description
botulinum toxin type A (Botox)2.5 units, 5 points
Intervention Type
Drug
Intervention Name(s)
pretarsal injection of Botulinum toxin type A
Other Intervention Name(s)
Botox
Intervention Description
Botulinum toxin type A 2,5 units, 5 points
Primary Outcome Measure Information:
Title
tear break up time
Description
unit of measure; minutes
Time Frame
change from baseline in tear break up time at 12 weeks
Secondary Outcome Measure Information:
Title
schirmer's test
Description
units of measurement; millimeters
Time Frame
change from baseline of schirmer's test at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient diagnosed with hemifacial spasm Exclusion Criteria: previous history of botulinum toxin treatment for hemifacial spasm ocular surface disorders tear disorders evidence of infection at or around eyelids pregnant woman other neurologic disease, i.e. OMG coagulopathy or treatment with thrombolytic agent treatment with aminoglycosides, chloroquine, hydroxychloroquine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kitthisak kitthaweesin, ND
Phone
6643348383
Email
kitthisak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kitthisak kithaweesin, MD
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khon Kaen University
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kitthisak kitthaweesin, MD
First Name & Middle Initial & Last Name & Degree
Pawat Phusetwong, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
8501266
Citation
Price J, O'Day J. A comparative study of tear secretion in blepharospasm and hemifacial spasm patients treated with botulinum toxin. J Clin Neuroophthalmol. 1993 Mar;13(1):67-71.
Results Reference
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Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm

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