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Corticosteroid

Dexamethasone Solution and Dexamethasone in Mucolox™

Phase 2
Waitlist Available
Led By Alessandro Villa, DDS, PhD, MPH
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new method using a special gel to apply a steroid medicine inside the mouth for patients with oral ulcers. The gel helps the medicine stay in place longer, reducing the frequency of application.

Eligible Conditions
  • Lichen Planus
  • Graft-versus-Host Disease
  • Pemphigus Vulgaris
  • Mucous Membrane Pemphigoid

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks
Secondary study objectives
Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: dexamethasone 0.5mg/5ml solution in Mucolox™ (group A)Experimental Treatment1 Intervention
Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks
Group II: dexamethasone 0.5mg/5ml solution (Arm B)Active Control1 Intervention
Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dexamethasone 0.5mg/5ml solution in Mucolox™
2020
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,591 Previous Clinical Trials
14,901,574 Total Patients Enrolled
Alessandro Villa, DDS, PhD, MPHPrincipal InvestigatorUniversity of California, San Francisco
~6 spots leftby Dec 2025
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