Status:
COMPLETED
The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Scleroderma
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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..
Exclusion
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04523506
Start Date
May 8 2020
End Date
April 22 2021
Last Update
April 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, United States, 75390-8802