Tacrolimus Ointment in Oral Lichen Planus

July 15, 2015 updated by: University of Oulu

Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70029
        • Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital
      • Oulu, Finland, 90014
        • Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tacrolimus
Tacrolimus ointment 0.1%, three times a day for 6-9 weeks.
Drug: 0.1 % tacrolimus ointment
applied topically to oral mucosa
Other Names:
  • Protopic
Active Comparator: Triamcinolone
Triamcinolone paste 0.1%, three times a day for 3-6 weeks.
Drug: 0.1 % triamcinolone paste
applied topically to oral mucosa
Other Names:
  • Kenacort-T paste, Kenacort-A paste
Placebo Comparator: Placebo
Orabase paste, three times a day for 3-6 weeks.
Drug: Orabase paste
applied topically to oral mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical score for OLP
Time Frame: 1,2,3,4,5,6,7,8 and 9 weeks, 6 months
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.
1,2,3,4,5,6,7,8 and 9 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Kuopio University Hospital

Investigators

  • Principal Investigator: Tuula Salo, DDS, PhD, Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Takrolimuusi123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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