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

NCT02142543 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-06-06

No results posted yet for this study

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.

Conditions

  • Minor Recurrent Aphthous Stomatitis Lesions

Interventions

DRUG

2-DeNT powder

powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum

DRUG

Placebo Comparator

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02142543 on ClinicalTrials.gov