Dexamethasone Solution and Dexamethasone in Mucolox™

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04540133
Collaborator
(none)
30
1
2
25.2
1.2

Study Details

Study Description

Brief Summary

Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. The primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative Diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved clinical outcomes due to the need for less frequent application.

Condition or Disease Intervention/Treatment Phase
  • Drug: dexamethasone 0.5mg/5ml solution
  • Drug: dexamethasone 0.5mg/5ml solution in Mucolox™
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases
Actual Study Start Date :
Dec 26, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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
Other Names:
  • dexamethasone solution in Mucolox™
  • Active Comparator: 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
    Other Names:
  • dexamethasone
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Change from Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks [4 weeks]

      Oral Pain Scores will be 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 [4 weeks]

      Oral lesions will be scored using the REU system. Reticular/hyperkeratotic changes will be scored from 0 to 1 (0 = no white striations, 1 = presence of white striations or keratotic papules); erosive/erythematous lesions will be scored 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 will be scored from 0 to 3 by area of involvement. 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 or Mann-Whitney test, depending on the distribution of the data.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Sol Silverman Oral Medicine Clinic - UCSF San Francisco California United States 94117

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Alessandro Villa, DDS, PhD, MPH, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04540133
    Other Study ID Numbers:
    • 20-32068
    First Posted:
    Sep 7, 2020
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2022