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Tacrolimus Ointment in Oral Lichen Planus

Information source: University of Oulu
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oral Lichen Planus

Intervention: 0.1 % tacrolimus ointment (Drug); 0.1 % triamcinolone paste (Drug); Orabase paste (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Oulu

Official(s) and/or principal investigator(s):
Tuula Salo, DDS, PhD, Principal Investigator, Affiliation: Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland

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).

Clinical Details

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

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

Primary outcome: Change in clinical score for OLP

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital, Kuopio 70029, Finland

Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu 90014, Finland

Additional Information

Starting date: August 2004
Last updated: July 15, 2015

Page last updated: August 23, 2015

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