Dexamethasone Solution for the Treatment of Oral Lichen Planus

• Status: Completed
• Trial end date: 2019-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pharmaceutical Solutions

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.