Dexamethasone Solution and Dexamethasone in Mucolox™
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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.