Tacrolimus Ointment in Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:

Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01544842
• Other study ID #: Takrolimuusi123
• Status: Terminated
• Phase: N/A
• First received: January 4, 2012
• Last updated: July 15, 2015
• Start date: August 2004
• Est. completion date: July 2015

Study information

• Verified date: December 2014
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFinland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• 0.1 % tacrolimus ointment
applied topically to oral mucosa
• 0.1 % triamcinolone paste
applied topically to oral mucosa
• Orabase paste
applied topically to oral mucosa

Locations

Country	Name	City	State
Finland	Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital	Kuopio
Finland	Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical score for OLP	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.	1,2,3,4,5,6,7,8 and 9 weeks, 6 months	No