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
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
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
NCT ID
NCT01544842
First Posted
January 4, 2012
Last Updated
July 15, 2015
Sponsor
University of Oulu
Collaborators
Kuopio University Hospital
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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