National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
Status: Not_yet_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: t
View:
• 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).
Locations
Other Locations
Brazil
EMS
Hortolândia
Time Frame
Start Date: 2024-09
Completion Date: 2025-09
Participants
Target number of participants: 232
Treatments
Experimental: BALI 25 + 25 + 15
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.
Placebo_comparator: PLACEBO
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.
Related Therapeutic Areas
Sponsors
Leads: EMS