Tacrolimus Ointment in Oral Lichen Planus

This study has been terminated.
(Lack of resources)
Sponsor:
Collaborator:
Kuopio University Hospital
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01544842
First received: January 4, 2012
Last updated: July 15, 2015
Last verified: December 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01544842     History of Changes
Other Study ID Numbers: Takrolimuusi123
Study First Received: January 4, 2012
Last Updated: July 15, 2015
Health Authority: Finland: Finnish Medicines Agency
Finland: Ethics Committee

Keywords provided by University of Oulu:
Oral lichen planus
Tacrolimus ointment
Triamcinolone paste

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Mouth Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Stomatognathic Diseases
Tacrolimus
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015