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Tacrolimus Ointment in Oral Lichen Planus

This study is currently recruiting participants.
Verified February 2012 by University of Oulu
Sponsor:
Collaborator:
Kuopio University Hospital
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01544842
First received: January 4, 2012
Last updated: March 5, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 40
Study Start Date: August 2004
Arms Assigned Interventions
Active Comparator: Tacrolimus Drug: 0.1 % tacrolimus ointment
Active Comparator: Triamcinolone Drug: 0.1 % triamcinolone paste
Placebo Comparator: Placebo Drug: Orabase paste

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544842

Contacts
Contact: Maria K Siponen, DDS +358 40 7353797 mariasiponen@yahoo.com
Contact: Tuula A Salo, DDS, PhD +358 40 5441560 tuula.salo@oulu.fi

Locations
Finland
Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Maria K Siponen, DDS     +358 40 7353797     mariasiponen@yahoo.com    
Principal Investigator: Maria K Siponen, DDS            
Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu Recruiting
Oulu, Finland, 90014
Contact: Tuula Salo, DDS, PhD     +358 40 5441560     tuula.salo@oulu.fi    
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: March 5, 2012
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
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Tacrolimus
Triamcinolone diacetate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013