NCT04540133

Dexamethasone Solution and Dexamethasone in Mucolox™

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Lichen Planus
• Mucous Membrane Pemphigoid
• Pemphigus Vulgaris
• Chronic Graft-versus-host-disease

Interventions

Type	Name	Description
DRUG	dexamethasone 0.5mg/5ml solution	Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate
DRUG	dexamethasone 0.5mg/5ml solution in Mucolox™	Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate

Timeline

• Start date: 2020-12-26
• Primary completion: 2023-01-06
• Completion: 2023-01-06
• First posted: 2020-09-07
• Last updated: 2023-12-15
• Results posted: 2023-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study