Aphthous mouth ulcers Oral Health Recurrent oral aphthae
Conditions
Interventions
This is a prospective, randomised, controlled, parallel-group open-label study, across two centres, investigating pain relief of aphthous ulcers (AU) with a barrier-forming gel, mouthwash, spray and p
Sponsors
Alliance Pharmaceuticals (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent and comply with study procedures 2. Healthy, male or female subjects aged =18 years old 3. Have an AU that began no more than 48 h prior to screening and is =2 mm and =10 mm in diameter 4. Have not more than six AU 5. Have a pain score =5.0 on the VAS at Screening without stimulus being applied 6. Fluent in the language of the study site and able to read in this language 7. Using a form of contraception with at least a 98% success rate when used correctly
Exclusion criteria
Exclusion criteria: 1. Have a known disorder or situation that causes mouth ulcers (including but not limited to connective tissue disorders and orthodontic devices) 2. Have a known allergy or known history of hypersensitivity to the components of the test device and/or related compounds 3. Clinically relevant abnormal medical history or physical findings at Screening that could interfere with the safety of the subject or objectives of the study 4. Have an oral disease, other than AU, that could interfere with the study 5. Have had oral surgery performed within 3 months prior to Screening 6. Have started taking medicines or using medical devices for the treatment of the outbreak of this AU 7. Ongoing pharmacological or device treatments that may interfere with the study (including but not limited to the use of herbal treatments, analgesics, antibiotics, and anti-inflammatories) 8. Use or intention to use any other topical treatments in the oral cavity or on the gums during the course of the study that might affect the study 9. Female subjects who are pregnant or breastfeeding 10. Female subjects who intend to conceive during the study 11. Drink more than 14 units of alcohol per week (female subjects) or more than 21 units per week of alcohol (male subjects) or who are not willing to abstain from alcohol during the period of the study 12. Do the following: smoke cigarettes, e-cigarettes, cigars or pipe, chew tobacco, use snuff or have used any of the aforementioned items within the last 3 months 13. Have a history of using drugs of abuse or have a positive test for drugs of abuse at the Screening visit 14. Subjects who, in the opinion of the Investigator, are not suitable for enrolment for another reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall pain as determined by the log area under the curve (AUC) of 10 cm visual analogue scale (VAS) pain scores measured over all stimulated time points (after 1 h) on Day 1 combined with overall pain scores from Days 2, 3 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The log AUC pain scores as measured by 10 cm VAS from Day 1 (0 to 8 h) only 2. Percentage reduction in unstimulated AU pain as measured by 10 cm VAS - calculation of baseline pain and pain at 5 and 30 minutes. A reduction of 20% will be classed as clinically important 3. Time stimulated pain relief (as measured by 10 cm VAS) is maintained at =20% from baseline scores: change in baseline score from baseline to 1, 2, 3, 4, 5, 6, 7 and 8 h 4. Pain when eating and drinking as measured by a Likert scale at the end of Days 2–4 5. Healing of lesion assessed by the clinician as healed, partially healed or unchanged at baseline and Day 5 6. Safety of devices as determined by reported adverse events during the study period 7. Stinging sensation upon first application measured using a rating out of 10 on site at first application | — |
Countries
Ukraine
Outcome results
None listed