Efficacy of Clobetasol, Ketoconazole and Amitryptiline Mouthwash on Oral Lichen Planus

Oral Lichen Planus (OLP) is a chronic inflammatory disease of oral mucosa, with an immunological origin. Atrophic/erosive OLP needs appropriate treatment, due to the pain and malignancy potential. Topical corticosteroids are the most effective drug therapy and mouthwashes are more effective topical dosage forms for this purpose. However, at present there are no corticosteroid mouthwashes available in Iran. In this study, the efficacy of a new mouthwash containing clobetasol, ketoconasole and amitriptyline was evaluated in comparison to the common treatment.

In this double blind randomized clinical trial study, 50 patients who had inclusion criteria were grouped randomly, with no difference in demographic data. The experimental group was treated using 5ml of mouthwash four times a day for 5 min, while the control group was treated by dexamethasone tablet, nystatin drop and diphenhydramine syrup.

Severity of the lesions and pain were followed as the chief complain and recorded in the initial, 1, 2, 4, 8 and 12 weeks intervals. All the collected data were analyzed with the Chi-Square, Mann-Whitney, student T-test and Mantel-Cox statistical tests, using the SPSS version 13 softwares.

There were significant differences in the pain reduction in the 1^st (P<0.001), 2^nd (P=0.01) and 12^th (P=0.025) weeks between the two groups, but the difference in weeks 4 (P=0.058) and 8 (P=0.131) were not significant. The lesion reduction was significantly higher in the experimental group (P<0.001). Complete resolution of lesions occurred on average after 2.65 and 10.75 weeks for the experimental and control groups, respectively. Also most patients in the experimental group (70.6%) had complete subjective satisfaction (75-100%) of treatment but most patients (43.8%) were mildly satisfied (0-25%) in the control group. Survival analysis showed that the possibility of existence of lesions after 3 months in the experimental group and control groups were 0% and 100% (P<0.001), respectively.

In conclusion, it seems that the new mouthwash is more effective in short term, with greater convenience for the patients.