Dexamethasone Solution and Dexamethasone in Mucolox™

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

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

Treatments: Drug: dexamethasone 0.5mg/5ml solution in Mucolox™; Drug: dexamethasone 0.5mg/5ml solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04540133

20-32068

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: dexamethasone 0.5mg/5ml solution in Mucolox™

dexamethasone 0.5mg/5ml solution (Arm B)

Active Comparator group

Description:

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

Treatment:

Drug: dexamethasone 0.5mg/5ml solution