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

Aphthous Stomatitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05542173
• Other study ID #: EMS0322 - BALI
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Drug:
• BALI association
BALI association oral suspension, 25 mg + 25 mg + 15 mg, oral. Three applications per day or more in case of pain, not exceeding six applications per day.
• Placebo
Placebo. Three applications per day or more in case of pain, not exceeding six applications per day.

Locations

Country	Name	City	State
Brazil	EMS	Hortolândia	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the reduction in pain intensity after 3 days of treatment.	Difference in pain intensity after 3 days of treatment compared to baseline. Pain intensity will be evaluated by the Visual Analogue Scale (VAS). The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").	3 days
Secondary	To assess the reduction in pain intensity after the first application.	Difference in pain intensity 15 minutes after the first application of the medication compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").	15 minutes
Secondary	To assess the reduction in pain intensity during the treatment.	Difference in pain intensity after 5 and 7 days of treatment compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").	5 and 7 days
Secondary	Percentage of participants healed during treatment.	Percentage of participants healed after 3, 5, and 7 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, measured by the Likert scale. Likert scale is a five point scale: 0 = no pain and 4 = pain as bad as it could possibly be".	3, 5 and 7 days
Secondary	Percentage of participants with no pain during treatment.	Percentage of participants with no pain after 3, 5, and 7 days of treatment, measured by the Likert scale. Likert scale is a five point scale: 0 = "no pain" and 4 = "pain as bad as it could possibly be".	3, 5 and 7 days
Secondary	To assess the percentage change in pain intensity from baseline during treatment.	Pain intensity will be evaluated by the VAS scale.The following calculations will be performed: ((D3, D5 or D7 - V0) / baseline) ×100%. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").	3, 5 and 7 days