Ulcer, Aphthous Clinical Trial
Official title:
Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition.
Despite advances in therapeutic means there is still necessary to find a way to alleviate
the local pain and discomfort induced by the mucosal ulceration.
The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in
the treatment of RAS.
Participants in the study will be examined for oral lesions, will be instructed how to apply
the oral-tablet, and will be interviewed during the follow-up period up to one week after
the application.
| Status | Suspended |
| Enrollment | 50 |
| Est. completion date | May 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria (in healthy individuals): - Age above 18 years old. - Non-pregnant women. - Healthy or controlled chronic diseases. - Examination at the Oral Medicine Clinic Inclusion Criteria (in RAS patients): - Age above 18 years old. - Non-pregnant women. - Clinical diagnosis of RAS. - Examination at the Oral Medicine Clinic Exclusion Criteria: - Oral lesion suspected to be malignant. - Ulcerative oral lesion other than RAS. - Another experimental oral intervention within the last 24 hours. - Pregnant women. - Allergy to components of the Pro-pe adhesive tablet |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization, | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization | Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland |
Israel,
Mizrahi B, Golenser J, Wolnerman JS, Domb AJ. Adhesive tablet effective for treating canker sores in humans. J Pharm Sci. 2004 Dec;93(12):2927-35. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers. |