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Tacrolimus Ointment in Oral Lichen Planus

This study has been terminated.
(Lack of resources)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544842
First Posted: March 6, 2012
Last Update Posted: July 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kuopio University Hospital
Information provided by (Responsible Party):
University of Oulu
  Purpose
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 Intervention
Oral Lichen Planus Drug: 0.1 % tacrolimus ointment Drug: 0.1 % triamcinolone paste Drug: Orabase paste

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: August 2004
Study Completion Date: July 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Locations
Finland
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
Investigators
Principal Investigator: Tuula Salo, DDS, PhD Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland
  More Information

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01544842     History of Changes
Other Study ID Numbers: Takrolimuusi123
First Submitted: January 4, 2012
First Posted: March 6, 2012
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:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Tacrolimus
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Triamcinolone
Benzocaine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents