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NCT04540133 · ClinicalTrials.gov registry record · Phase 2
Dexamethasone Solution and Dexamethasone in Mucolox™
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT04540133 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 29 participants.
The verdict
NCT04540133, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. The primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative Diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved clinical outcomes due to the need for less frequent application.
Interventions
- DRUG dexamethasone 0.5mg/5ml solution
- DRUG dexamethasone 0.5mg/5ml solution in Mucolox™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2020-12-26 |
| Est. Completion | 2023-01-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04540133
The ClinicalTrials.gov registry entry for NCT04540133 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which dexamethasone 0.5mg/5ml solution is the first listed.
NCT04540133 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04540133 about?
NCT04540133 is a clinical study titled "Dexamethasone Solution and Dexamethasone in Mucolox™". Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively...
What is the current status of trial NCT04540133?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2020-12-26. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT04540133?
The interventions under investigation include: dexamethasone 0.5mg/5ml solution (DRUG), dexamethasone 0.5mg/5ml solution in Mucolox™ (DRUG).
Who is sponsoring clinical trial NCT04540133?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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