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

March 27, 2012 updated by: kitthisak kitthaweesin, Khon Kaen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Khon Kaen University
        • Principal Investigator:
          • kitthisak kitthaweesin, MD
        • Principal Investigator:
          • Pawat Phusetwong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preseptal
Drug: preseptal injection of botulinum toxin type A
botulinum toxin type A (Botox)2.5 units, 5 points
Other Names:
  • Botox
Experimental: pretarsal
Drug: pretarsal injection of Botulinum toxin type A
Botulinum toxin type A 2,5 units, 5 points
Other Names:
  • Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tear break up time
Time Frame: change from baseline in tear break up time at 12 weeks
unit of measure; minutes
change from baseline in tear break up time at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
schirmer's test
Time Frame: change from baseline of schirmer's test at 12 weeks
units of measurement; millimeters
change from baseline of schirmer's test at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: kitthisak kithaweesin, MD, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 18, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTS-001-BTX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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