Clinical Trial: The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Brief 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.
Detailed Summary:
Sponsor: Texas A&M University
Current Primary Outcome: Ulcer size [ Time Frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Erythema [ Time Frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days ]
Original Secondary Outcome: Same as current
Information By: Texas A&M University
Dates:
Date Received: April 24, 2014
Date Started: March 2012
Date Completion:
Last Updated: June 4, 2014
Last Verified: June 2014