Overview

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

Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
EMS
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.