Clinical trial: The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer (NCT02142543)

Eligibility criteria:
Inclusion Criteria:

          -  a history of minor recurrent aphthous stomatitis (RAS) lesions occurring at least 3-4
             time/ year, and usually requiring 5 or more days to resolve

          -  presence of an active ulcer of less than 48 hours duration on either the buccal or
             labial mucosa (making them more easily accessible for powder application)

          -  willing and able to give informed consent

        Exclusion Criteria:

          -  pregnant or lactating

          -  if ulcers were manifestations of a systemic disease process such as ulcerative
             colitis, Crohn's disease, Behcet's syndrome, or anemia;

          -  concurrent clinical conditions that could either pose a health risk to the patient by
             being involved in the study or potentially influence the outcome of the study

          -  hypersensitivity to dexamethasone, diphenhydramine, tetracycline, metronidazole,
             nystatin, karaya gum, or zinc oxide

          -  having used corticosteroids, oral retinoids, or other immunomodulatory agents within
             one month of participation in the study; non-steroidal anti-inflammatory agents (e.g.,
             aspirin, ibuprofen, etc.), acetaminophen, or oral antihistamines chronically within
             one month of participation in the study or any use within five days of participation
             in the study; topical medication (including steroids, retinoids, and anti-microbial
             drugs) within two weeks of participation in the study, systemic antibiotics within two
             weeks of participation in the study; any preparation or medication (OTC or
             prescription) applied to the ulcer within 48 hours of participation in the study

          -  history of drug or alcohol abuse

          -  having had any dental work within 2 weeks of study entry

          -  having had any orthodontic or oral appliances (that could cause oral trauma) within 1
             cm of the ulcer or any recollection of trauma in the area of the ulcer

          -  participating in any other study involving investigational or marketed products within
             1 month of study entry or plans to participate in such an investigation during this
             study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Entailment