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

Brief Title

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

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

Brief Summary

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

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

To assess the reduction in pain intensity after 3 days of treatment.

Secondary Outcome

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

Condition

Aphthous Stomatitis

Intervention

BALI association

Study Arms / Comparison Groups

 BALI 25 + 25 + 15

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

232

Start Date

September 2023

Completion Date

September 2025

Primary Completion Date

September 2025

Eligibility 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.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Brazil

Location Countries

Brazil

NCT ID

NCT05542173

Organization ID

EMS0322 - BALI

Responsible Party

Sponsor

Study Sponsor

EMS

Study Sponsor

, , 

Verification Date

September 2022