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NCT05995626 · ClinicalTrials.gov registry record · Early Phase 1
Hyaluronidase Via LADD Scleroderma-induced Microstomia
A Early Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT05995626: Completed Early Phase 1 study, sponsored by University of Nebraska.
NCT05995626 is a Early Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05995626, a Early Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previously reported for the treatment of scleroderma-induced microstomia. By using this laser technique, the investigator can reduce the pain of typical hyaluronidase injections and reap the therapeutic benefit of the laser treatment itself. The investigator's goal is to create greater mouth mobility for chewing and speaking as well as improved oral hygiene, self-esteem, and overall quality of life. Each participant will undergo three separate laser sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three months after the last laser session to evaluate the response.
Primary Outcome
The aim is to increase interincisal distance. Measurements will be collected before and after every treatment and on follow-up visit.
Interventions
- DEVICE CO2 laser
- DRUG Hyaluronidase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2024-09-24 |
| Phase | Early Phase 1 |
What the finished NCT05995626 record still lists
NCT05995626 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which CO2 laser is the first listed.
NCT05995626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05995626 about?
NCT05995626 is a clinical study titled "Hyaluronidase Via LADD Scleroderma-induced Microstomia". Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previousl...
What is the current status of trial NCT05995626?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2024-03-01. Estimated completion is 2024-09-24.
What interventions are being tested in trial NCT05995626?
The interventions under investigation include: CO2 laser (DEVICE), Hyaluronidase (DRUG).
Who is sponsoring clinical trial NCT05995626?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05995626's enrollment target sits among peer trials
3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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