Tacrolimus Ointment in Oral Lichen Planus

Not Applicable

Terminated

• Conditions: Oral Lichen Planus
• Interventions: Drug: 0.1 % triamcinolone paste; Drug: 0.1 % tacrolimus ointment; Drug: Orabase paste

• Registration Number: NCT01544842
• Lead Sponsor: University of Oulu

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Status Verified: 2014-12
• Primary Completion: 2015-02
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcinolone	0.1 % triamcinolone paste	Triamcinolone paste 0.1%, three times a day for 3-6 weeks.
Tacrolimus	0.1 % tacrolimus ointment	Tacrolimus ointment 0.1%, three times a day for 6-9 weeks.
Placebo	Orabase paste	Orabase paste, three times a day for 3-6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in clinical score for OLP	1,2,3,4,5,6,7,8 and 9 weeks, 6 months	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.

Trial Locations

Locations (2)

Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu; 🇫🇮 Oulu, Finland

Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital; 🇫🇮 Kuopio, Finland