HEALTH
Conditions
Interventions
Subjects were instructed to apply 1 pellicle to that identified ulcer 4 times a day for 5 days.
Sponsors
Beijing Fu Rei Kang Zheng Medical and Pharmaceutical Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18-60 years old; 2. Willingness to participate and sign the informed consent forms; 3. Presenting with 1 to 5 aphthous ulcers (less than 72 hours duration) with a size no greater than 5 mm in diameter; 4. An expectation that their ulcers normally take 5 or more days to resolve without treatment; 5. Normal sense of pain, without anesthesia or paresthesia.
Exclusion criteria
Exclusion criteria: 1. A known history of serious drug hypersensitivities; 2. Pregnancy and lactation (Urine hCG-positive); 3. Concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions; 4. A history of an immunologic problem; 5. Ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Crohns disease, Behcet¡s syndrome, or serious anemia; 6. Treatment with systemic steroid or other immunomodulatory agents within 1 month before the study entry; 7. Use of nonsteroidal anti-inflamatory drugs or oral antihistamines within 1 month prior to the study entry; 8. Treatment of the ulcer with any preparation or medication within 72 hours prior to the study entry; 9. Treatment with systemic antibiotics within 2 weeks prior to the study entry; 10. Attendance of any other clinical trials within 3 months prior to the study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amlexanox oral adhesive pellicles significantly reduced ulcer size and alleviated ulcer pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythema exudation. | — |
Contacts
Public ContactChen Qianming
Outcome results
None listed