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The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma

Primary Purpose

Scleroderma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin(Botox)
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Ddiagnosis of scleroderma (defined by the 2013 Classification Criteria for Systemic Sclerosis4,5)23,24 ) who also have microstomia (reduced oral aperture), defined as an inter-incisal distance less than 50 mm 6-7)m13,14 .
  2. Male and female subjects.
  3. English and non-English speakers.
  4. Subjects aged 18 years old to 65 years old will be considered

Exclusion Criteria

  1. Patients under 18 years old will be excluded.
  2. Patients with a known history of a hypersensitivity to any Botox formulation or to any of the components in the formulation,
  3. Active skin infection at the proposed injection site.
  4. Concomitant neuromuscular disorder.
  5. Pregnant or lactating.
  6. Missing incisors.
  7. treatment with: cyclophosphamide, Ultraviolet A-1 therapy, or topical calcitriol..

Sites / Locations

  • UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

the temporomandibular joint (TMJ) group

the perioral group

Arm Description

This study will evaluate the use of botulinum toxin for microstomia (reduced oral aperture) in scleroderma patients. The TMJ group will be injected with two units of Botox into four different injection points to each masseter (16 units of Botox total) at the initial visit. No additional Botox will be injected in subsequent visits. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1

Biological/Vaccine: Botulinum toxin(Botox) This study will evaluate the use of botulinum toxin for microstomia (reduced oral aperture) in scleroderma patients. The perioral group will be injected with two units of Botox into eight different injection points (16 units of Botox total) around the lips (in the orbicularis oris). Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3.

Outcomes

Primary Outcome Measures

Changes in inter-labial distance
Inter-labial distance is defined as the distance between the upper and lower lip at maximum mouth opening. Distance will be measured using digital calipers by the same operator
Changes interincisal distance
Interincisal distance is defined by the didistance between upper and lower incisor at maximum mouth opening. Distance will be measured using digital calipers by the same operator
quality of life via a Skindex16 survey
This is a patient quality of life survey using the skindex 16 survey form.

Secondary Outcome Measures

Changes in the inter-commissural distance
Inter-commissural distance is defined by the distance from corner to corner at the angle of the lip (also known as the oral commissures). Distance will be measured using digital calipers by the same operator.
Changes in the Mouth Handicap in Systemic Sclerosis Scale (MHISS)
Mouth disability will be assessed via the Mouth Handicap in Systemic Sclerosis Scale (MHISS). MHISS range from 0 to 48 with 48 being worse disability

Full Information

First Posted
July 19, 2020
Last Updated
April 27, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04523506
Brief Title
The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma
Official Title
The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
April 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the use of botulinum toxin for microstomia (also known as reduced oral aperture) in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3. The study will include three arms: the temporomandibular joint (TMJ) group who will receive injections of Botox to the masseter, the perioral group who will receive injections of Botox around the lips, and a control group who will receive no treatment for ROA. Outcome measurements will include measurement of oral aperture size through measurement inter-labial distance and between the upper and lower lips and the inter-incisal distance, patient satisfaction via a Skindex16 survey, mouth disability via the Mouth Handicap in Systemic Sclerosis Scale (MHISS), and patient and physician satisfaction using the Visual Analogic Scale (VAS). The maximum number of subjects to be consented for this study is 30. The study is expected to last four months per subject from time of consent to last clinical evaluation. Conditions that may result in a subject exiting the study prior to completion date include non-compliance, withdrawal of consent, or safety concerns such as adverse events as a result of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the temporomandibular joint (TMJ) group
Arm Type
Experimental
Arm Description
This study will evaluate the use of botulinum toxin for microstomia (reduced oral aperture) in scleroderma patients. The TMJ group will be injected with two units of Botox into four different injection points to each masseter (16 units of Botox total) at the initial visit. No additional Botox will be injected in subsequent visits. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1
Arm Title
the perioral group
Arm Type
Experimental
Arm Description
Biological/Vaccine: Botulinum toxin(Botox) This study will evaluate the use of botulinum toxin for microstomia (reduced oral aperture) in scleroderma patients. The perioral group will be injected with two units of Botox into eight different injection points (16 units of Botox total) around the lips (in the orbicularis oris). Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3.
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin(Botox)
Intervention Description
This study will evaluate the use of botulinum toxin for reduced oral aperture in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase.
Primary Outcome Measure Information:
Title
Changes in inter-labial distance
Description
Inter-labial distance is defined as the distance between the upper and lower lip at maximum mouth opening. Distance will be measured using digital calipers by the same operator
Time Frame
This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Title
Changes interincisal distance
Description
Interincisal distance is defined by the didistance between upper and lower incisor at maximum mouth opening. Distance will be measured using digital calipers by the same operator
Time Frame
This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Title
quality of life via a Skindex16 survey
Description
This is a patient quality of life survey using the skindex 16 survey form.
Time Frame
This information will be collected at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Secondary Outcome Measure Information:
Title
Changes in the inter-commissural distance
Description
Inter-commissural distance is defined by the distance from corner to corner at the angle of the lip (also known as the oral commissures). Distance will be measured using digital calipers by the same operator.
Time Frame
This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.]
Title
Changes in the Mouth Handicap in Systemic Sclerosis Scale (MHISS)
Description
Mouth disability will be assessed via the Mouth Handicap in Systemic Sclerosis Scale (MHISS). MHISS range from 0 to 48 with 48 being worse disability
Time Frame
This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ddiagnosis of scleroderma (defined by the 2013 Classification Criteria for Systemic Sclerosis4,5)23,24 ) who also have microstomia (reduced oral aperture), defined as an inter-incisal distance less than 50 mm 6-7)m13,14 . Male and female subjects. English and non-English speakers. Subjects aged 18 years old to 65 years old will be considered Exclusion Criteria Patients under 18 years old will be excluded. Patients with a known history of a hypersensitivity to any Botox formulation or to any of the components in the formulation, Active skin infection at the proposed injection site. Concomitant neuromuscular disorder. Pregnant or lactating. Missing incisors. treatment with: cyclophosphamide, Ultraviolet A-1 therapy, or topical calcitriol..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Goff, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
To be decided by research team

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The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma

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