Phase 2
N=24
Dexamethasone Solution for the Treatment of Oral Lichen Planus
Lichen Planus
Bottom Line
View on ClinicalTrials.gov: NCT02850601 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
May 2021
Primary outcome: Primary: Change in Oral Sensitivity — -4.5; -6.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oral Sensitivity |
-4.5; -6.0 | — |
Summary
The objective of this single center, 4-week, open label randomized, phase II study is to evaluate and characterize the tolerability and clinical effectiveness of dexamethasone 0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen planus.
Eligibility Criteria
Inclusion Criteria
- Age 18 years and older.
- Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).
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.
Data sourced from ClinicalTrials.gov (NCT02850601). 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.