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

January 4, 2012
July 15, 2015
August 2004
February 2015   (final data collection date for primary outcome measure)
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Not Provided
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
    applied topically to oral mucosa
    Other Name: Protopic
  • Drug: 0.1 % triamcinolone paste
    applied topically to oral mucosa
    Other Name: Kenacort-T paste, Kenacort-A paste
  • Drug: Orabase paste
    applied topically to oral mucosa
  • Active Comparator: Tacrolimus
    Tacrolimus ointment 0.1%, three times a day for 6-9 weeks.
    Intervention: Drug: 0.1 % tacrolimus ointment
  • Active Comparator: Triamcinolone
    Triamcinolone paste 0.1%, three times a day for 3-6 weeks.
    Intervention: Drug: 0.1 % triamcinolone paste
  • Placebo Comparator: Placebo
    Orabase paste, three times a day for 3-6 weeks.
    Intervention: Drug: Orabase paste
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
28
July 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01544842
Takrolimuusi123
No
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
December 2014

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