Topical tacrolimus, triamcinolone acetonide, and placebo in oral lichen planus: a pilot randomized controlled trial

Abstract

Objective: To carry out a double-blind randomized controlled trial (RCT) to compare the effectiveness of topical tacrolimus (TAC), triamcinolone acetonide (TRI), and placebo (PLA) in symptomatic oral lichen planus (OLP).

Subjects and methods: A clinical score (CS, range 0-130) was developed to measure the clinical signs and symptoms of OLP. Twenty-seven OLP patients with a CS of ≥20 were randomly allocated to receive 0.1% TAC ointment (n = 11), 0.1% TRI paste (n = 7), or Orabase^® paste as PLA (n = 9) for 3 weeks. If the CS dropped ≥20% (interpreted as response), the patients continued the same medication for another 3 weeks. If the CS dropped <20% or increased (non-response), the patients were switched to TAC for 6 weeks. A 6-month follow-up period ensued. The primary outcome variable was the change in CS from baseline to week 3. In primary outcome analysis, CS values between the treatment arms were compared.

Results: Tacrolimus and TRI were more effective (P = 0.012 and 0.031, respectively) than PLA in reducing the CS at week 3. No difference in the efficacy was noted between TAC and TRI (P = 0.997).

Conclusions: This pilot RCT provides evidence for the effectiveness of TAC and TRI over PLA in the management of OLP.

Keywords: clinical trial; oral lichen planus; placebo; randomized controlled trial; tacrolimus; triamcinolone.