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

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523506
• Other study ID #: STU-2020-0169
• Status: Completed
• Phase: Early Phase 1
• Start date: May 8, 2020
• Est. completion date: April 22, 2021

Study information

• Verified date: April 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 22, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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..

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Biological:
• Botulinum toxin(Botox)
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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Primary	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	This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Primary	quality of life via a Skindex16 survey	This is a patient quality of life survey using the skindex 16 survey form.	This information will be collected at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Secondary	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.	This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.]
Secondary	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	This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.]