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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Khon Kaen University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
kitthisak kitthaweesin, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01564979
First received: March 18, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Hemifacial Spasm
Drug: preseptal injection of botulinum toxin type A
Drug: pretarsal injection of Botulinum toxin type A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • tear break up time [ Time Frame: change from baseline in tear break up time at 12 weeks ] [ Designated as safety issue: Yes ]
    unit of measure; minutes


Secondary Outcome Measures:
  • schirmer's test [ Time Frame: change from baseline of schirmer's test at 12 weeks ] [ Designated as safety issue: Yes ]
    units of measurement; millimeters


Estimated Enrollment: 26
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preseptal Drug: preseptal injection of botulinum toxin type A
botulinum toxin type A (Botox)2.5 units, 5 points
Other Name: Botox
Experimental: pretarsal Drug: pretarsal injection of Botulinum toxin type A
Botulinum toxin type A 2,5 units, 5 points
Other Name: Botox

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564979

Contacts
Contact: kitthisak kitthaweesin, ND 6643348383 kitthisak@hotmail.com

Locations
Thailand
Khon Kaen University Not yet recruiting
Muang, Khon Kaen, Thailand, 40002
Principal Investigator: kitthisak kitthaweesin, MD         
Principal Investigator: Pawat Phusetwong, MD         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: kitthisak kithaweesin, MD Khon Kaen University
  More Information

Publications:
Responsible Party: kitthisak kitthaweesin, Assoc Prof, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01564979     History of Changes
Other Study ID Numbers: KTS-001-BTX
Study First Received: March 18, 2012
Last Updated: March 27, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
United States: Food and Drug Administration

Keywords provided by Khon Kaen University:
botulinum toxin
facial nerve
hemifacial spasm
tears

Additional relevant MeSH terms:
Spasm
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014