Topical tacrolimus, triamcinolone acetonide, and placebo in oral lichen planus: a pilot randomized controlled trial.
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.
Institute of Dentistry, University of Oulu, Oulu, Finland.|Cancer and Translational Medicine Research Unit, University of Oulu, Oulu, Finland.|Department of Oral and Maxillofacial Diseases, Kuopio University Hospital, Kuopio, Finland.
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http://orcid.org/0000-0003-2357-830X
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Siponen
Institute of Dentistry, University of Oulu, Oulu, Finland.
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L
Huuskonen
Institute of Dentistry, University of Oulu, Oulu, Finland.
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Kallio-Pulkkinen
Medical Informatics and Statistics Research Group, University of Oulu, Oulu, Finland.
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P
Nieminen
Institute of Dentistry, University of Oulu, Oulu, Finland.|Cancer and Translational Medicine Research Unit, University of Oulu, Oulu, Finland.|Department of Oral and Maxillofacial Diseases, University of Helsinki, Helsinki, Finland.|Medical Research Center, Oulu University Hospital, Oulu, Finland.
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Salo
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000627:therapeutic use*; D014222:Triamcinolone Acetonide / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D014222:Triamcinolone Acetonide; D016559:Tacrolimus
clinical trial; oral lichen planus; placebo; randomized controlled trial; tacrolimus; triamcinolone