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Corticosteroid

dexamethasone 0.5mg/5ml solution in Mucolox™ for Oral Lichen Planus

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

Study Summary

This trial is testing whether a new way of delivering a topical steroid medication to the mouth via Mucolox™ is more effective and tolerable than the current standard method for treating Oral Inflammatory Ulcerative Diseases.

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

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

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

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
2,518 Previous Clinical Trials
15,241,700 Total Patients Enrolled
1 Trials studying Oral Lichen Planus
Alessandro Villa, DDS, PhD, MPHPrincipal InvestigatorUniversity of California, San Francisco
~7 spots leftby Jun 2025
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