Phase 2
N=29
Dexamethasone Solution and Dexamethasone in Mucolox™
Oral Lichen Planus · Mucous Membrane Pemphigoid · Pemphigus Vulgaris · Chronic Graft-versus-host-disease
Bottom Line
View on ClinicalTrials.gov: NCT04540133 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks — 6.3; 4.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dexamethasone 0.5mg/5ml solution (Drug); dexamethasone 0.5mg/5ml solution in Mucolox™ (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks |
6.3; 4.4 | — |
| SECONDARY Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks |
2.5; 3.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04540133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.