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

National, Multicenter, Randomized, Double-blind, Pilot Study to Evaluate the Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis

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

Study Overview

• Status: Recruiting
• Conditions: Aphthous Stomatitis
• Intervention / Treatment: Drug: BNP105 (25 + 25 + 15); Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Jau, SP, Brazil, 17210-190
      • Recruiting
      • CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
      • Contact: Edilaine S Sabio; Phone Number: +5514 36023535; Email: cecipjau@gmail.com
      • Principal Investigator: Flávia A P M da Costa, Dr
  • São Paulo
    • Hortolândia, São Paulo, Brazil, 13183-250
      • Not yet recruiting
      • EMS
      • Contact: Cassiano Ricardo O Berto; Phone Number: +551938877724; Email: pesquisa.clinica@ncfarma.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: BNP105 (25 + 25 + 15); BNP105 oral suspension, 25 mg + 25 mg + 15 mg, oral. Up to six applications per day.
Placebo Comparator: 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.	Other: Placebo; Placebo. Up to six applications per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the change in pain intensity after the first application.	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").	3 and 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the pain intensity daily after breakfast, lunch and dinner.	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").	7 days
To assess the pain intensity daily at night.	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").	7 days
To assess the oral health-related quality of life	The oral health-related quality of life will be evaluated daily at night by the adapted Oral Health Impact Profile (OHIP) questionary.	7 days
Percentage of participants healed after 3 days of treatment.	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").	3 days
Percentage of participants with no pain after 3 days of treatment.	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").	3 days
To assess the change 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 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").	3 days
Global assessment of treatment by participant after 3 days of treatment	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.	3 days

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Aphthous Stomatitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Aphthous
• Other Study ID Numbers: BNP105-P-0123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No