Dexamethasone Solution for the Treatment of Oral Lichen Planus

NCT02850601 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2016D003018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lichen Planus

Keywords

Oral lichen planus; Dexamethasone solution

Outcome Measures

Primary Outcomes (1)

• Change in Oral Sensitivity

  Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline. Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated.

  4 weeks after the start of the trial

Study Arms (2)

Dexamethasone solution

EXPERIMENTAL

Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks

Drug: Dexamethasone

Dexamethasone solution in Mucolox™

ACTIVE COMPARATOR

Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate

Also known as: Decadron Elixir

Dexamethasone solution; Dexamethasone solution in Mucolox™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older.
• Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).

You may not qualify 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Lichen Planus; Lichen Planus, Oral

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Herve Sroussi
• Organization: BWH

hsroussi@bwh.harvard.edu

617 5256864

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral Medicine Attending

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 1, 2016
• Study Start: February 7, 2017
• Primary Completion: December 19, 2019
• Study Completion: December 20, 2019
• Last Updated: June 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-05

Locations

US (1)