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NCT04523506 · ClinicalTrials.gov registry record · Early Phase 1
The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma
A Early Phase 1 study of Scleroderma, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04523506: Completed Early Phase 1 study of Scleroderma, sponsored by University of Texas Southwestern Medical Center.
NCT04523506 is a Early Phase 1 study of Scleroderma that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 17 participants, below the 402-participant average among 23 other Scleroderma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04523506, a Early Phase 1 study of Scleroderma, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL Botulinum toxin(Botox)
Study Locations (1)
Texas
- UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-05-08 |
| Est. Completion | 2021-04-22 |
| Phase | Early Phase 1 |
What the finished NCT04523506 record still lists
NCT04523506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 402-participant average among 23 other Scleroderma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Scleroderma appearing as the primary indexed condition, and to 1 intervention - of which Botulinum toxin(Botox) is the first listed.
NCT04523506 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04523506 about?
NCT04523506 is a clinical study titled "The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma". 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 differen...
What is the current status of trial NCT04523506?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2020-05-08. Estimated completion is 2021-04-22.
What conditions does trial NCT04523506 study?
This clinical trial studies the following conditions: Scleroderma.
What interventions are being tested in trial NCT04523506?
The interventions under investigation include: Botulinum toxin(Botox) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04523506?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04523506 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04523506's enrollment target sits among peer trials
17 22nd of 23 higher than 2 of 23 other Scleroderma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Scleroderma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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