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

Abstract

Objective

To carry out a double-blind RCT to compare the effectiveness of topical tacrolimus (TAC), triamcinolone acetonide (TRI) and placebo (PLA) in symptomatic 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

TAC 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.

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