Topical tacrolimus, triamcinolone acetonide, and placebo in oral lichen planus : a pilot randomized controlled trial
Siponen, M; Huuskonen, L; Kallio‐Pulkkinen, S; Nieminen, P; Salo, T (2017-03-31)
Siponen, M et al. Topical tacrolimus, triamcinolone acetonide, and placebo in oral lichen planus : a pilot randomized controlled trial. Oral Diseases (2017) 23, 660–668. http://dx.doi.org/10.1111/odi.12653
© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. All rights reserved. This is the peer reviewed version of the following article: Oral Diseases (2017) 23, 660–668., which has been published in final form at http://dx.doi.org/10.1111/odi.12653. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
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).
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.
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