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Tacrolimus Ointment in Oral Lichen Planus

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ClinicalTrials.gov Identifier: NCT01544842
Recruitment Status : Terminated (Lack of resources)
First Posted : March 6, 2012
Last Update Posted : July 17, 2015
Kuopio University Hospital
Information provided by (Responsible Party):
University of Oulu

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).

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: 0.1 % tacrolimus ointment Drug: 0.1 % triamcinolone paste Drug: Orabase paste Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus
Study Start Date : August 2004
Actual Primary Completion Date : February 2015
Actual Study Completion Date : July 2015

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 Name: 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 Name: 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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544842

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Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital
Kuopio, Finland, 70029
Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Kuopio University Hospital
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Principal Investigator: Tuula Salo, DDS, PhD Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01544842    
Other Study ID Numbers: Takrolimuusi123
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: December 2014
Keywords provided by University of Oulu:
Oral lichen planus
Tacrolimus ointment
Triamcinolone paste
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists