Clinical trial NCT05542173: Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
Official title: National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Aphthous Stomatitis
Keywords: Aphthous Stomatitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2022-09-15
Enrollment: 232
Sex: ALL
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 BALI association in the treatment of aphthous ulceration.


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;
* Minor recurrent aphthous ulceration with onset of symptoms within 48 hours;
* Moderate to severe baseline pain, with VAS ≥ 4 (EVA scale).

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 reduction in pain intensity after 3 days of treatment.
timeFrame: 3 days
Secondary outcomes:
measure: To assess the reduction in pain intensity after the first application.
timeFrame: 15 minutes
measure: To assess the reduction in pain intensity during the treatment.
timeFrame: 5 and 7 days
measure: Percentage of participants healed during treatment.
timeFrame: 3, 5 and 7 days
measure: Percentage of participants with no pain during treatment.
timeFrame: 3, 5 and 7 days
measure: To assess the percentage change in pain intensity from baseline during treatment.
timeFrame: 3, 5 and 7 days
Other outcomes:
Locations:
city: Hortolândia
country: Brazil
facility: EMS
state: São Paulo
Study officials:
References: