Tacrolimus Ointment in Oral Lichen Planus

NCT ID: NCT01544842

Last Updated: 2015-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2015-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tacrolimus

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

Group Type ACTIVE_COMPARATOR

0.1 % tacrolimus ointment

Intervention Type DRUG

applied topically to oral mucosa

Triamcinolone

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

Group Type ACTIVE_COMPARATOR

0.1 % triamcinolone paste

Intervention Type DRUG

applied topically to oral mucosa

Placebo

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

Group Type PLACEBO_COMPARATOR

Orabase paste

Intervention Type DRUG

applied topically to oral mucosa

Interventions

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0.1 % tacrolimus ointment

applied topically to oral mucosa

Intervention Type DRUG

0.1 % triamcinolone paste

applied topically to oral mucosa

Intervention Type DRUG

Orabase paste

applied topically to oral mucosa

Intervention Type DRUG

Other Intervention Names

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Protopic Kenacort-T paste, Kenacort-A paste

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tuula Salo, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital

Kuopio, , Finland

Site Status

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

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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Takrolimuusi123

Identifier Type: -

Identifier Source: org_study_id

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