Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis

Not Applicable

Recruiting

• Conditions: Aphthous Stomatitis
• Interventions: Drug: BNP105 (25 + 25 + 15); Other: Placebo

• Registration Number: NCT05772338
• Lead Sponsor: EMS

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of BNP105 in the treatment of recurrent aphthous stomatitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Study Start: 2024-01-22
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-01
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 102

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;
• One minor recurrent aphthous stomatitis with onset of symptoms within 48 hours;
• Moderate to severe baseline pain, with VAS ≥ 60 mm (EVA scale 0-100 mm).

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BNP105 (25 + 25 + 15)	BNP105 (25 + 25 + 15)	Up to 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	Placebo	Up to 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.

Primary Outcome Measures

Name	Time	Method
To assess the change in pain intensity after the first application.	3 and 10 minutes	Difference in pain intensity 3 and 10 minutes after the first application of the medication compared to baseline, measured by the VAS scale. The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").

Secondary Outcome Measures

Name	Time	Method
Global assessment of treatment by participant after 3 days of treatment	3 days	The global evaluation of the treatment after 3 days of treatment will be evaluated by the categorical scale of 5 points representing 0 = very bad, 1 = bad, 2 = indifferent, 3 = good and 4 = very good.
To assess the change in pain intensity after 3 days of treatment.	3 days	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 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
To assess the pain intensity daily at night.	7 days	Pain intensity will be evaluated daily at night by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
To assess the oral health-related quality of life	7 days	The oral health-related quality of life will be evaluated daily at night by the adapted Oral Health Impact Profile (OHIP) questionary.
Percentage of participants healed after 3 days of treatment.	3 days	Percentage of participants healed after 3 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, measured by the VAS scale. The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
To assess the pain intensity daily after breakfast, lunch and dinner.	7 days	Pain intensity will be evaluated daily after breakfast, lunch and dinner by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
Percentage of participants with no pain after 3 days of treatment.	3 days	Percentage of participants with no pain after 3 days of treatment, defined as pain intensity = 0, measured by the VAS scale. The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").

Trial Locations

Locations (2)

EMS; 🇧🇷 Hortolândia, São Paulo, Brazil

Cecip Jau - Centro de Estudos Clinicos Do Interior Paulista Ltda; 🇧🇷 Jau, SP, Brazil