Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis

National, Multicenter, Randomized, Double-blind, Pilot Study to Evaluate the Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis

The purpose of this study is to evaluate the efficacy and safety of BNP105 in the treatment of recurrent aphthous stomatitis.

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Age greater than or equal to 12 years;
• One minor recurrent aphthous stomatitis with onset of symptoms within 48 hours;
• Moderate to severe baseline pain, with VAS ≥ 60 mm (EVA scale 0-100 mm).

Exclusion Criteria:

• Any clinical findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Participants diagnosed with: Behcet's disease, rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, Reiter's syndrome, Crohn's disease, ulcerative colitis);
• Participants with diseases that affect healing (e.g. diabetes);
• Immunocompromised participants;
• Participants with aphthous herpetiform ulceration or major aphthous ulceration;
• Participants using medication to treat oral ulcerations (systemic or local);
• Participants who used analgesics or anti-inflammatory drugs in the 6 hours prior to the beginning of the study;
• Participants who used systemic antibiotics in the 2 weeks prior to the beginning of the study;
• Participants using medications that can confuse pain assessment (psychotropics, antidepressants and sedative-hypnotics), except when on a stable dose for at least 30 days prior to the screening visit, and the dose cannot be changed during the clinical trial;
• Participants with current smoking habits.
• Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
• Known hypersensitivity to the formula components used during the clinical trial;
• Participants with current or medical history of cancer in the last 5 years;
• Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.