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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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..

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04523506
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Texas Southwestern Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Heather Goff, MD
Principal Investigator Affiliation UT Southwestern Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scleroderma
Arms & Interventions

Arms

Experimental: the temporomandibular joint (TMJ) group

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

Experimental: the perioral group

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Dallas, Texas, 75390-8802

Site Contact

Seli Gyau, M.S

[email protected]

214-645-8968