Tacrolimus Ointment in Oral Lichen Planus

University of Oulu28 enrolled

Overview

The purpose of this study is to compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Oral Lichen Planus

Interventions

0.1 % tacrolimus ointmentDRUG

applied topically to oral mucosa

0.1 % triamcinolone pasteDRUG

applied topically to oral mucosa

Orabase pasteDRUG

applied topically to oral mucosa

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of OLP made by a specialist in oral pathology based on clinical and histopathological features * Clinical score for OLP ≥ 20 at baseline * Symptomatic OLP at baseline * Washout period of 2 weeks * Age over 18 Exclusion Criteria: * Pregnant or lactating women * Allergy to tacrolimus or other macrolides * Allergy to other drugs or substances used in the study * Abnormal liver function * Netherton's syndrome * Cyclosporin medication * Other regular medication that could have significant interactions with tacrolimus

Locations (2)

Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital

Kuopio, Finland

Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu

Oulu, Finland

Outcomes

Primary Outcomes

Change in clinical score for OLP

The clinical score for OLP is a measure designed by the investigators for assessing the clinical extent and type of OLP, and the symptoms experienced by the patient. The value of the score is between 0-120.

Time frame: 1,2,3,4,5,6,7,8 and 9 weeks, 6 months

Data from ClinicalTrials.gov

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