NCT01544842

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 17, 2015

Status Verified

December 1, 2014

Enrollment Period

10.5 years

First QC Date

January 4, 2012

Last Update Submit

July 15, 2015

Conditions

Oral Lichen Planus

Keywords

Oral lichen planusTacrolimus ointmentTriamcinolone paste

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus ointment 0.1%, three times a day for 6-9 weeks.

Drug: 0.1 % tacrolimus ointment

Triamcinolone

ACTIVE COMPARATOR

Triamcinolone paste 0.1%, three times a day for 3-6 weeks.

Drug: 0.1 % triamcinolone paste

Placebo

PLACEBO COMPARATOR

Orabase paste, three times a day for 3-6 weeks.

Drug: Orabase paste

Interventions

0.1 % tacrolimus ointmentDRUG

applied topically to oral mucosa

Also known as: Protopic
Tacrolimus
0.1 % triamcinolone pasteDRUG

applied topically to oral mucosa

Also known as: Kenacort-T paste, Kenacort-A paste
Triamcinolone
Orabase pasteDRUG

applied topically to oral mucosa

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital

Kuopio, 70029, Finland

Location

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

Oulu, 90014, Finland

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Tuula Salo, DDS, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

March 6, 2012

Study Start

August 1, 2004

Primary Completion

February 1, 2015

Study Completion

July 1, 2015

Last Updated

July 17, 2015

Record last verified: 2014-12

Locations

FI(2)