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NCT Number: NCT04540133

Dexamethasone Solution and Dexamethasone in Mucolox™

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.

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Key information

Conditions

Oral Lichen Planus Autoimmune Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Graft-versus-host-disease Conjunctival Diseases Eye Diseases Graft vs Host Disease Immune System Diseases Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Lung Diseases Lung Diseases, Obstructive Mouth Diseases Mucous Membrane Pemphigoid Organizing Pneumonia Pemphigoid, Benign Mucous Membrane Pemphigus Pemphigus Vulgaris Respiratory Tract Diseases Skin Diseases Skin Diseases, Papulosquamous Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sol Silverman Oral Medicine Clinic - UCSF

San Francisco, California, 94117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dexamethasone 0.5mg/5ml solution

Drug

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

dexamethasone 0.5mg/5ml solution in Mucolox™

Drug

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™

Primary outcomes

  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 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 outcomes

  1. Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2020
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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