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Dexamethasone Solution and Dexamethasone in Mucolox™

Primary Purpose

Oral Lichen Planus, Mucous Membrane Pemphigoid, Pemphigus Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone 0.5mg/5ml solution
dexamethasone 0.5mg/5ml solution in Mucolox™
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sol Silverman Oral Medicine Clinic - UCSF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dexamethasone 0.5mg/5ml solution in Mucolox™ (group A)

dexamethasone 0.5mg/5ml solution (Arm B)

Arm Description

Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks

Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks

Outcomes

Primary Outcome Measures

Mean Change from Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 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

Mean Change from Baseline in Reticulation/keratosis, erythema, and ulceration (REU) scores at 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.

Full Information

First Posted
August 28, 2020
Last Updated
January 6, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04540133
Brief Title
Dexamethasone Solution and Dexamethasone in Mucolox™
Official Title
Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 26, 2020 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
January 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus, Mucous Membrane Pemphigoid, Pemphigus Vulgaris, Chronic Graft-versus-host-disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone 0.5mg/5ml solution in Mucolox™ (group A)
Arm Type
Experimental
Arm Description
Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks
Arm Title
dexamethasone 0.5mg/5ml solution (Arm B)
Arm Type
Active Comparator
Arm Description
Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks
Intervention Type
Drug
Intervention Name(s)
dexamethasone 0.5mg/5ml solution
Other Intervention Name(s)
dexamethasone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
dexamethasone 0.5mg/5ml solution in Mucolox™
Other Intervention Name(s)
dexamethasone solution in Mucolox™
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Reticulation/keratosis, erythema, and ulceration (REU) scores at 4 Weeks
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Villa, DDS, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sol Silverman Oral Medicine Clinic - UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Final results will be submitted for publication on a peer reviewed journal

Learn more about this trial

Dexamethasone Solution and Dexamethasone in Mucolox™

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