Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations

EMS

Status and phase: Not yet enrolling; Phase 3

Conditions: Aphthous Stomatitis

Treatments: Drug: BALI association; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05542173

EMS0322 - BALI

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.

Enrollment: 232 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups, including a placebo group

BALI 25 + 25 + 15

Experimental group

Description:

Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.

Treatment:

Drug: BALI association

PLACEBO

Placebo Comparator group

Description:

Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.

Treatment:

Drug: Placebo