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Dexamethasone Solution and Dexamethasone in Mucolox™

NCT ID: NCT04540133

Last Updated: 2023-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-26

Study Completion Date

2023-01-06

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

dexamethasone 0.5mg/5ml solution in Mucolox™

Intervention Type 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

dexamethasone 0.5mg/5ml solution (Arm B)

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

Group Type ACTIVE_COMPARATOR

dexamethasone 0.5mg/5ml solution

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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dexamethasone dexamethasone solution in Mucolox™

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandro Villa, DDS, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Sol Silverman Oral Medicine Clinic - UCSF

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37549933 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-32068

Identifier Type: -

Identifier Source: org_study_id