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An evaluation on the efficacy and safety of dexamethasone ointment in the treatment of recurrent aphthous ulceration: a randomized, double-blinded, placebo controlled, parallel, multicenter clinical trial

An evaluation on the efficacy and safety of dexamethasone ointment in the treatment of recurrent aphthous ulceration: a randomized, double-blinded, placebo controlled, parallel, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001106
Enrollment
Unknown
Registered
2010-12-06
Start date
2009-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent aphthous ulceration

Interventions

experimental group:Placebo 3 times a day, for 5 days
control group:dexamethasone ointment 3 times a day, for 5 days

Sponsors

West China College of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 60 years old; 2. more than six months of the history of RAU and with expectation that the ulcers normally take more than 5 days to resolve without treatment; 3. presenting with 1-3 aphthous ulcers (<48 hours' duration) with a size <10 mm in diameter; 4. ulcers must be in locations easily accessible for evaluation and treatment; 5. negative reaction to pregnancy test in women.

Exclusion criteria

Exclusion criteria: 1. history of allergies to dexamethasone or a known history of serious drug hypersensitivities; 2. major aphthous ulcer, herpetiform ulcer, Behcet's disease, premenarcheal ulcer or with other severe oral mucosal diseases; 3. using any agents for ulcers during the previous 48 hours; 4. orthodontic braces or retainer that might come into contact with the ulcer; 5. those with severe systemic diseases or abnormal hepatic or renal function test; 6. pregnancy or intention of pregnancy or lactation or use of contraceptives of steroid hormone recently; 7. history of psychiatric disorders; 8. being addicted to smoking and alcohol; 9. attendance of any other clinical trials prior to 3 months of entering this study.

Design outcomes

Primary

MeasureTime frame
duration and healing ratio of the ulcers;

Secondary

MeasureTime frame
ulcer size, pain index;

Countries

China

Contacts

Public ContactHongmei Zhou
acomnet@126.com+86 028 85503480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026