Dexamethasone Solution and Dexamethasone in Mucolox™

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified October 2023 by University of California, San Francisco
Sponsor
University of California, San Francisco
Information Provided by (Responsible Party)
University of California, San Francisco
Clinicaltrials.gov Identifier
NCT04540133
Other Study ID Numbers:
20-32068
First Submitted
August 27, 2020
First Posted
September 6, 2020
Results First Posted
November 5, 2023
Last Update Posted
December 14, 2023
Last Verified
October 2023

ClinicalTrials.gov processed this data on November 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Oral Lichen PlanusMucous Membrane PemphigoidPemphigus VulgarisChronic Graft-versus-host-disease
Drug: dexamethasone 0.5mg/5ml solution in Mucolox™Drug: dexamethasone 0.5mg/5ml solution

Study Design

Study TypeInterventional
Actual Enrollment29 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleDexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases
Study Start DateDecember 25, 2020
Actual Primary Completion DateJanuary 5, 2023
Actual Study Completion DateJanuary 5, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
dexamethasone 0.5mg/5ml solution in Mucolox™ (group A)
Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks
Drug: dexamethasone 0.5mg/5ml solution in Mucolox™
Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate
dexamethasone 0.5mg/5ml solution (Arm B)
Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks
Drug: dexamethasone 0.5mg/5ml solution
Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate

Outcome Measures

Primary Outcome Measures
  1. Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks
    Oral Pain Scores were measured on the Visual Analog Scale (VAS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. The pain score measured on a VAS scale will be compared between group A and group B to detect any significant differences pre and post treatment at 4 weeks.
Secondary Outcome Measures
  1. Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks
    Oral lesions were scored using the REU (reticulation,erythema and ulcer) system (form 0 till 49.5). Reticulations were scored from 0 to 1 (0 = no white striations, 1 = presence of white striations or keratotic papules); erythematous lesions from 0 to 3 by area of involvement (0 = no lesion, 1 = lesions less than 1 cm2, 2 = lesions from 1 to 3 cm2, 3 = lesions greater than 3 cm2); ulcers from 0 to 3 by area of involvement. The higher is the score the more severe is the disease. In order to evaluate the clinical improvement in clinician-reported outcome measures for oral lesions, REU scores within the compound dexamethasone solution in Mucolox™ group (Arm A) will be compared to that in the dexamethasone solution only group (Arm B). The REU scores will be summarized descriptively for each arm at pre-treatment, post-treatment, and pre-to-post treatment change. The pre-to-post treatment change will be compared between the arms using either student's t-test o

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Age 18 years and older.
Patients with symptomatic biopsy proven Oral Inflammatory Ulcerative Diseases (worst VAS sensitivity score ≥ 7 over the last week).
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
Patients already on topical or systemic steroids.
Inability to comply with study instructions.
Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
VAS sensitivity score \< 7.
Pregnant women. A urine pregnancy test will be performed for women of child bearing potential.
Allergy to fluconazole.

Contacts and Locations

Sponsors and CollaboratorsUniversity of California, San Francisco
Locations
Sol Silverman Oral Medicine Clinic - UCSF | San Francisco California, United States, 94117
Investigators
Principal Investigator: Alessandro Villa, DDS, PhD, MPH, University of California, San Francisco
Study Documents (Full Text)
Documents provided by University of California, San Francisco: Study Protocol and Statistical Analysis Plan  November 17, 2020