Comparison of topical tacrolimus and clobetasol in the management of symptomatic oral lichen planus: A double-blinded, randomized clinical trial in Sri Lanka

Abstract

Aim: Oral lichen planus (OLP) is a common, chronic inflammatory disease of the oral mucosa. Although several studies have shown the efficacy of different treatment modalities, a definitive cure has not yet been established. The present trial compares the effectiveness of topically-applied clobetasol and tacrolimus in the symptomatic management of OLP.

Methods: A randomized, comparative, double-blind study with 68 patients (43 females, 25 males; mean age: 46.76 years) was undertaken. Patients were randomly divided into two groups of 34 patients each to receive topical tacrolimus 0.1% cream or clobetasol propionate 0.05% cream for 3 weeks.

Results: After 3 weeks of treatment, the mean pain score dropped by 1.59 (right) and 1.53 (left) in the tacrolimus group, while in clobetasol group these values were 0.94 and 0.85, respectively. The mean scores for clinical appearance reduced by 1.18 (right) and 1.0 (left) in the tacrolimus group compared with a reduction of 0.5 and 0.26, respectively, in the clobetasol group. These reductions were statistically significant (P < .05).

Conclusion: The results suggest that tacrolimus 0.1% cream is an effective alternative to topical steroid and can be considered a first-line therapy in OLP. However, further studies are needed to confirm the effectiveness of this treatment before it is recommended for use in clinical practice.

Keywords: clobetasol; mucosal lesion; oral lichen planus; randomized clinical trial; tacrolimus.