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Status unknownNCT01564979Updated Mar 28, 2012

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

A Phase 2 interventional study of preseptal injection of botulinum toxin type A and pretarsal injection of Botulinum toxin type A in Hemifacial Spasm, sponsored by Khon Kaen University. Status unknown at 1 site in Thailand. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-28.

Sponsored by Khon Kaen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Hemifacial Spasm

Keywords

  • botulinum toxin
  • facial nerve
  • hemifacial spasm
  • tears
03

In context

Hemifacial Spasm

23 studies on the registry are indexed under Hemifacial Spasm; 3 are open to participants now.

This study's planned enrollment of 26 is below the median of 61 across 11 interventional studies indexed under Hemifacial Spasm.

Browse Hemifacial Spasm studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 161 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient diagnosed with hemifacial spasm

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    preseptal

    Drug: preseptal injection of botulinum toxin type A

  • Experimental
    pretarsal

    Drug: pretarsal injection of Botulinum toxin type A

Interventions

06

What researchers measure

Primary outcomes

  1. tear break up time

    unit of measure; minutes

    Time frame: change from baseline in tear break up time at 12 weeks

Secondary outcomes

  1. schirmer's test

    units of measurement; millimeters

    Time frame: change from baseline of schirmer's test at 12 weeks

07

Study locations

1 site
  • Khon Kaen University
    Muang, Khon Kaen 40002, Thailand
    • kitthisak kitthaweesin, MD · Principal investigator
    • Pawat Phusetwong, MD · Principal investigator
08

References and documents

Publications

  • 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. PubMed 8501266 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01564979
Responsible party
kitthisak kitthaweesin (Assoc Prof, Khon Kaen University) — Principal investigator
First posted
Mar 28, 2012
Start date
Apr 2012
Primary completion
Sep 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Mar 28, 2012

Study contacts

kitthisak kitthaweesin, ND
Contact
kitthisak@hotmail.com
6643348383
kitthisak kithaweesin, MD
principal investigator · Khon Kaen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Onabotulinum toxin A

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