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

NCT05542173 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EMS0322 - BALI
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aphthous Stomatitis

Keywords

Aphthous Stomatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To assess the reduction in pain intensity after the first application.

  15 minutes

• To assess the reduction in pain intensity during the treatment.

  5 and 7 days

• Percentage of participants healed during treatment.

  3, 5 and 7 days

• Percentage of participants with no pain during treatment.

  3, 5 and 7 days

• To assess the percentage change in pain intensity from baseline during treatment.

  3, 5 and 7 days

Study Arms (2)

BALI 25 + 25 + 15

EXPERIMENTAL

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.

Drug: BALI association

PLACEBO

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

BALI association DRUG

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.

BALI 25 + 25 + 15

Placebo DRUG

Placebo. Three applications per day or more in case of pain, not exceeding six applications per day.

PLACEBO

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

EMS

Hortolândia, São Paulo, Brazil

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)