Tacrolimus Ointment in Oral Lichen Planus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Oulu.
Recruitment status was  Recruiting
Kuopio University Hospital
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
First received: January 4, 2012
Last updated: March 5, 2012
Last verified: February 2012

January 4, 2012
March 5, 2012
August 2004
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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.
Same as current
Complete list of historical versions of study NCT01544842 on ClinicalTrials.gov Archive Site
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Tacrolimus Ointment in Oral Lichen Planus
Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus

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).

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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Oral Lichen Planus
  • Drug: 0.1 % tacrolimus ointment
  • Drug: 0.1 % triamcinolone paste
  • Drug: Orabase paste
  • Active Comparator: Tacrolimus
    Intervention: Drug: 0.1 % tacrolimus ointment
  • Active Comparator: Triamcinolone
    Intervention: Drug: 0.1 % triamcinolone paste
  • Placebo Comparator: Placebo
    Intervention: Drug: Orabase paste
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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
18 Years and older
Contact: Maria K Siponen, DDS +358 40 7353797 mariasiponen@yahoo.com
Contact: Tuula A Salo, DDS, PhD +358 40 5441560 tuula.salo@oulu.fi
University of Oulu
University of Oulu
Kuopio University Hospital
Principal Investigator: Tuula Salo, DDS, PhD Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland
University of Oulu
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP