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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
2,500 Previous Clinical Trials
15,236,442 Total Patients Enrolled
1 Trials studying Oral Lichen Planus
Alessandro Villa, DDS, PhD, MPHPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has dexamethasone 0.5mg/5ml solution in Mucolox™ been investigated in any additional research?

"Presently, there are 552 dexamethasone 0.5mg/5ml solution in Mucolox™ clinical trials taking place globally with 144 of those being Phase 3 studies. The majority of these investigations originate from Mishawaka, Indiana although 18606 sites across the world are involved as well."

Answered by AI

Are individuals being recruited for participation in this experiment presently?

"Per the information provided by clinicaltrials.gov, this trial is actively enrolling participants and has been since its initial posting on December 26th 2020. Its most recent update was registered on March 21st 2022."

Answered by AI

What are the standard applications of dexamethasone 0.5mg/5ml solution in Mucolox™?

"Dexamethasone 0.5mg/5ml solution in Mucolox™ is often given to patients dealing with ophthalmia, sympathetic and other eye related issues such as branch retinal vein occlusion or macular edema."

Answered by AI

What is the current recruitment level for this investigation?

"Affirmative. Clinicaltrials.gov reflects that this research endeavour, originally posted on December 26th 2020, is actively searching for participants with 30 individuals needed from one location."

Answered by AI

Does the FDA certify dexamethasone 0.5mg/5ml solution found in Mucolox™?

"Due to limited efficacy data, the safety of dexamethasone 0.5mg/5ml solution in Mucolox™ was rated a 2 on our assessment scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dexamethasone Solution and Dexamethasone in Mucolox™
2020. "Dexamethasone Solution and Dexamethasone in Mucolox™". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04540133.
~7 spots leftby Apr 2025
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