Treatment of recurrent aphthous stomatitis with an intra-oral patch
- Conditions
- Recurrent aphthous stomatitis (RAS)Oral Health
- Registration Number
- ISRCTN15873887
- Lead Sponsor
- Mucocort AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 50
1. Males or females, 12 -70 years of age
2. =2 RAS episodes over the past 6 months
3. =3 wounds at the time of the study visit
4. The diameter of the wounds <10 mm
5. The pain from RAS =4 on the NRS
6. The subjects should have the ability and willingness to provide informed consent
1. Treated at any time with mucosal topical, oral, or systemic corticosteroids less than 1 month prior to screening.
2. On TNF-alpha modulating drugs or DMARDs less than 1 month prior to screening
3. Suffering from any oral mucosal disease other than RAS at the time of enrollment
4. Any other condition as judged by the investigator to make the investigation inappropriate
5. Current alcohol or substance abuse
6. Participating in any other clinical trial or have participated in any other clinical trial within 1 month prior to the study start
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity measured using a numeric rating scale (NRS) at baseline and 10 minutes
- Secondary Outcome Measures
Name Time Method 1. Pain intensity measured using a NRS at baseline and 1, 2, 4, 6, and 8 hours<br>2. Inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety or performance will be reported as a device deficiency without unnecessary delay to the Sponsor by using the device deficiency form. It is the PI’s responsibility to record every observed device deficiency together with an assessment. The Sponsor will review all device deficiencies and determine and document in writing whether they could have led to a Serious Adverse Event (SAE).<br>3. Quality of life measured using EQ-5D-5L at 2 hours<br>4. Quality of life measured using Oral Health Impact Profile-14 (OHIP-14) scores at 2 hours