Clinical trial NCT05772338: Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis
Official title: National, Multicenter, Randomized, Double-blind, Pilot Study to Evaluate the Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aphthous Stomatitis
Keywords: Aphthous Stomatitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2023-03-16
Enrollment: 102
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the change in pain intensity after the first application.
timeFrame: 3 and 10 minutes
Secondary outcomes:
measure: To assess the change in pain intensity after 3 days of treatment.
timeFrame: 3 days
measure: To assess the pain intensity daily after breakfast, lunch and dinner.
timeFrame: 7 days
measure: To assess the pain intensity daily at night.
timeFrame: 7 days
measure: To assess the oral health-related quality of life
timeFrame: 7 days
measure: Percentage of participants healed after 3 days of treatment.
timeFrame: 3 days
measure: Percentage of participants with no pain after 3 days of treatment.
timeFrame: 3 days
measure: Global assessment of treatment by participant after 3 days of treatment
timeFrame: 3 days
Other outcomes:
Locations:
city: Jau
country: Brazil
facility: Cecip Jau - Centro de Estudos Clinicos Do Interior Paulista Ltda
state: SP
city: Hortolândia
country: Brazil
facility: EMS
state: São Paulo
Study officials:
References: