Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations (NCT05542173) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
Brazil232 participantsStarted 2024-09
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pregn…
What they're measuring
1
To assess the reduction in pain intensity after 3 days of treatment.