## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** KTS-001-BTX
#### Organization
**Class:** OTHER
**Full Name:** Khon Kaen University
### Status Module
#### Completion Date
**Date:** 2012-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2012-03-28

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-03-27

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2012-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-04

**Status Verified Date:** 2012-03

#### Study First Post Date
**Date:** 2012-03-28
**Type:** ESTIMATED
**Study First Submit Date:** 2012-03-18
**Study First Submit QC Date:** 2012-03-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Khon Kaen University

#### Responsible Party

**Investigator Affiliation:** Khon Kaen University

**Investigator Full Name:** kitthisak kitthaweesin

**Investigator Title:** Assoc Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hemifacial Spasm

**Keywords:**

- botulinum toxin

- facial nerve

- hemifacial spasm

- tears

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 26

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: preseptal injection of botulinum toxin type A

**Label:** preseptal

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: pretarsal injection of Botulinum toxin type A

**Label:** pretarsal

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- preseptal

**Description:** botulinum toxin type A (Botox)2.5 units, 5 points

**Name:** preseptal injection of botulinum toxin type A

**Other Names:**

- Botox

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- pretarsal

**Description:** Botulinum toxin type A 2,5 units, 5 points

**Name:** pretarsal injection of Botulinum toxin type A

**Other Names:**

- Botox

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** unit of measure; minutes

**Measure:** tear break up time

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

#### Secondary Outcomes

**Description:** units of measurement; millimeters

**Measure:** schirmer's test

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

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kitthisak@hotmail.com

**Name:** kitthisak kitthaweesin, ND

**Phone:** 6643348383

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Muang

**Contacts:**

***Contact 1:***

- **Name:** kitthisak kitthaweesin, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 2:***

- **Name:** Pawat Phusetwong, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Thailand

**Facility:** Khon Kaen University

**State:** Khon Kaen

**Zip:** 40002

#### Overall Officials

**Official 1:**

**Affiliation:** Khon Kaen University

**Name:** kitthisak kithaweesin, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 8501266

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2015-05-31

- Date Unknown: Unknown

#### Event: RESET

- Date: 2015-06-15

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M15837

- Name: Spasm

- Relevance: HIGH

- As Found: Spasm

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M12077

- Name: Muscle Cramp

- Relevance: HIGH

- As Found: Spasm

- ID: M21505

- Name: Hemifacial Spasm

- Relevance: HIGH

- As Found: Hemifacial Spasm

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009120

- Term: Muscle Cramp

- ID: D000019569

- Term: Hemifacial Spasm

- ID: D000013035

- Term: Spasm

### Intervention Browse Module - Ancestors

- ID: D000065087

- Term: Acetylcholine Release Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M5183

- Name: Botulinum Toxins

- Relevance: HIGH

- As Found: Face

- ID: M21257

- Name: Botulinum Toxins, Type A

- Relevance: HIGH

- As Found: Weight loss

- ID: M250193

- Name: abobotulinumtoxinA

- Relevance: HIGH

- As Found: Weight loss

- ID: M3473

- Name: Acetylcholine

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001905

- Term: Botulinum Toxins

- ID: D000019274

- Term: Botulinum Toxins, Type A

- ID: C000542869

- Term: abobotulinumtoxinA

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2015-05-31

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2015-05-31

- Reset Date: 2015-06-15

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
