Dexamethasone Solution and Dexamethasone in Mucolox™

NCT04540133 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-32068
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus; Mucous Membrane Pemphigoid; Pemphigus Vulgaris; Chronic Graft-versus-host-disease

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (2)

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

EXPERIMENTAL

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™

dexamethasone 0.5mg/5ml solution (Arm B)

ACTIVE COMPARATOR

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

Drug: dexamethasone 0.5mg/5ml solution

Interventions

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

Also known as: dexamethasone

dexamethasone 0.5mg/5ml solution (Arm B)

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

Also known as: dexamethasone solution in Mucolox™

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Sol Silverman Oral Medicine Clinic - UCSF

San Francisco, California, 94117, United States

Location

Related Publications (1)

• Lodolo M, Thanasuwat B, Veluppillai P, Bassani G, Villa A. Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral inflammatory ulcerative diseases: A phase II randomized clinical trial. J Oral Pathol Med. 2023 Oct;52(9):860-866. doi: 10.1111/jop.13471. Epub 2023 Aug 7.

  PMID: 37549933 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral; Pemphigoid, Benign Mucous Membrane; Pemphigus; Bronchiolitis Obliterans Syndrome

Interventions

Dexamethasone; Solutions

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Conjunctival Diseases; Eye Diseases; Skin Diseases, Vesiculobullous; Autoimmune Diseases; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Alessandro Villa
• Organization: UCSF

Alessandro.Villa@ucsf.edu

415-476-2045

Study Officials

• Alessandro Villa, DDS, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 7, 2020
• Study Start: December 26, 2020
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)