University of Oulu

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.

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

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Author: Siponen, M1,2,3; Huuskonen, L1; Kallio‐Pulkkinen, S1;
Organizations: 1University of Oulu Institute of Dentistry Oulu Finland
2University of Oulu Cancer and Translational Medicine Research Unit Oulu Finland
3Kuopio University Hospital Department of Oral and Maxillofacial Diseases Kuopio Finland
4University of Oulu Medical Informatics and Statistics Research Group Oulu Finland
5University of Helsinki Department of Oral and Maxillofacial Diseases Helsinki Finland
6Oulu University Hospital Medical Research Center Oulu Finland
Format: article
Version: accepted version
Access: open
Online Access: PDF Full Text (PDF, 0.1 MB)
Persistent link:
Language: English
Published: John Wiley & Sons, 2017
Publish Date: 2018-03-31


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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Series: Oral diseases
ISSN: 1354-523X
ISSN-E: 1601-0825
ISSN-L: 1354-523X
Volume: 23
Issue: 5
Pages: 660 - 668
DOI: 10.1111/odi.12653
Type of Publication: A1 Journal article – refereed
Field of Science: 3122 Cancers
Funding: This study was financially supported by Finnish Dental Society Apollonia, EVO Funds Oulu University Hospital, EVO/VTR Funds Kuopio University Hospital, Sigrid Juselius Foundation, and MRC Oulu University Hospital.
Copyright information: © 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 This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.