Promising results for dexamethasome ointment for treatment of recurrent aphthae

Randomised controlled trial.

Patients were randomised to receive either a 5 g tube of dexamethasone ointment (containing 5 mg dexamethasone) [n=120] or placebo ointment [n=120]. Participants were instructed to apply the given agents to the ulcer three times a day (after meals) for five days. The initial application of the medication was performed under observation for >30 minutes for any signs of adverse effects. Patients kept a daily log and were reviewed clinically on day 6 ± 2.

The size, pain level, healing ratio, average duration of ulcers and the safety of the agents were evaluated. The serum concentration of dexamethasone was monitored.

After 6 ± 2 days of treatment, there was significant difference in the ulcer size between the treatment group (7.167± 6.3415 mm²) and the control group (4.346 ± 7.0666 mm²; P=.000), and in the variation of pain level between the treatment group (5.623± 1.9570) and the control group (4.940± 2.2449; P=.001). The healing ratio was 83.33% in the treatment group and 54.70% in the control group (P=.000). No severe adverse reactions were observed. No serum dexamethasone was detected before or after the use of the agents (<0.502 ng/mL).

The current study revealed that dexamethasone ointment was safe and efficient in reducing ulcer size, alleviating ulcer pain and hastening ulcer healing in patients with recurrent aphthous ulceration. In addition, the patients had a good overall assessment of the agents. We could not detect dexamethasone in the serum of patients, which illustrated further the safety of dexamethasone ointment.