Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Alessandro Villa, DDS, PhD, MPH

Description

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.

Official Title

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

Keywords

Oral Lichen Planus Mucous Membrane Pemphigoid Pemphigus Vulgaris Chronic Graft-versus-host-disease Lichen Planus, Oral Pemphigoid, Benign Mucous Membrane Lichen Planus Pemphigoid, Bullous Pemphigus Graft vs Host Disease Dexamethasone Dexamethasone acetate Pharmaceutical Solutions BB 1101 dexamethasone 0.5mg/5ml solution dexamethasone 0.5mg/5ml solution in Mucolox™

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Location

  • Sol Silverman Oral Medicine Clinic - UCSF
    San Francisco California 94117 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04540133
Phase
Phase 2
Study Type
Interventional
Last Updated