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Dexamethasone Solution and Dexamethasone in Mucolox™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540133
Recruitment Status : Not yet recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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
Oral Lichen Planus Mucous Membrane Pemphigoid Pemphigus Vulgaris Chronic Graft-versus-host-disease Drug: dexamethasone 0.5mg/5ml solution Drug: dexamethasone 0.5mg/5ml solution in Mucolox™ Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : February 2023


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 Name: 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 Name: dexamethasone




Primary Outcome Measures :
  1. Mean Change from Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540133


Contacts
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Contact: Alessandro Villa, DDS, PhD, MPH (415) 476-2045 alessandro.villa@ucsf.edu

Locations
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United States, California
Sol Silverman Oral Medicine Clinic - UCSF
San Francisco, California, United States, 94117
Contact: Alessandro Villa, DDS, PhD, MPH       alessandro.villa@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Alessandro Villa, DDS, PhD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04540133    
Other Study ID Numbers: 20-32068
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Final results will be submitted for publication on a peer reviewed journal

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pemphigus
Lichen Planus, Oral
Pemphigoid, Benign Mucous Membrane
Lichen Planus
Pemphigoid, Bullous
Graft vs Host Disease
Immune System Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Conjunctival Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
Pharmaceutical Solutions
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal