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

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

Official Title
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National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations

Conditions
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Aphthous Stomatitis

Intervention / Treatment
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* Drug: BALI association
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BALI 25 + 25 + 15<br>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<br>* 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.<br>|
| Placebo Comparator: PLACEBO<br>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<br>* Placebo. Three applications per day or more in case of pain, not exceeding six applications per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphthous Stomatitis