drugset / Trial / NCT02142543

The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer

NCT02142543

Phase 0 Completed 23 enrolled Texas A&M University
RandomizedCrossoverTriple-blindTreatment

Summary

This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of less than 48 hours duration. It was randomly determined which powder was used first; all subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder twice daily and maintained a daily log recording the size of the ulcer, its erythema score, and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer was resolved.

Timeline

Start
2012-03
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule
Subject Diphenhydramine Unknown
Subject Metronidazole Small molecule
Subject Nystatin Unknown
Subject Tetracycline Unknown

Indications