The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma
Scleroderma
About this trial
This is an interventional treatment trial for Scleroderma
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..
Sites / Locations
- UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
the temporomandibular joint (TMJ) group
the perioral 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
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.