Tacrolimus Ointment in Oral Lichen Planus

University of Oulu

Status: Terminated

Conditions: Oral Lichen Planus

Treatments: Drug: Orabase paste; Drug: 0.1 % triamcinolone paste; Drug: 0.1 % tacrolimus ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT01544842

Takrolimuusi123

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 3 patient groups, including a placebo group

Tacrolimus

Active Comparator group

Description:

Tacrolimus ointment 0.1%, three times a day for 6-9 weeks.

Treatment:

Drug: 0.1 % tacrolimus ointment

Triamcinolone

Active Comparator group

Description:

Triamcinolone paste 0.1%, three times a day for 3-6 weeks.

Treatment:

Drug: 0.1 % triamcinolone paste

Placebo

Placebo Comparator group

Description:

Orabase paste, three times a day for 3-6 weeks.

Treatment:

Drug: Orabase paste