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Corticosteroid
dexamethasone 0.5mg/5ml solution in Mucolox™ for Graft-versus-Host Disease
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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
2,580 Previous Clinical Trials
15,177,471 Total Patients Enrolled
Alessandro Villa, DDS, PhD, MPHPrincipal InvestigatorUniversity of California, San Francisco
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