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Tacrolimus Ointment in Oral Lichen Planus

Primary Purpose

Oral Lichen Planus

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
0.1 % tacrolimus ointment
0.1 % triamcinolone paste
Orabase paste
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, Tacrolimus ointment, Triamcinolone paste

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Tacrolimus

Triamcinolone

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2012
Last Updated
July 15, 2015
Sponsor
University of Oulu
Collaborators
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01544842
Brief Title
Tacrolimus Ointment in Oral Lichen Planus
Official Title
Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of resources
Study Start Date
August 2004 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
Oral lichen planus, Tacrolimus ointment, Triamcinolone paste

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus
Arm Type
Active Comparator
Arm Description
Tacrolimus ointment 0.1%, three times a day for 6-9 weeks.
Arm Title
Triamcinolone
Arm Type
Active Comparator
Arm Description
Triamcinolone paste 0.1%, three times a day for 3-6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orabase paste, three times a day for 3-6 weeks.
Intervention Type
Drug
Intervention Name(s)
0.1 % tacrolimus ointment
Other Intervention Name(s)
Protopic
Intervention Description
applied topically to oral mucosa
Intervention Type
Drug
Intervention Name(s)
0.1 % triamcinolone paste
Other Intervention Name(s)
Kenacort-T paste, Kenacort-A paste
Intervention Description
applied topically to oral mucosa
Intervention Type
Drug
Intervention Name(s)
Orabase paste
Intervention Description
applied topically to oral mucosa
Primary Outcome Measure Information:
Title
Change in clinical score for OLP
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuula Salo, DDS, PhD
Organizational Affiliation
Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70029
Country
Finland
Facility Name
Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu
City
Oulu
ZIP/Postal Code
90014
Country
Finland

12. IPD Sharing Statement

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Tacrolimus Ointment in Oral Lichen Planus

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