Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.

Detailed Description

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Oral lichen planus is a mucosal inflammatory disease of unknown origin. It can be very painful especially if erosions appear on the oral mucosa.

In this study the efficacy of pimecrolimus compared to placebo in treatment of erosive oral lichen planus will be investigated. To this end the subjective pain and the amount of affected mucosa will be monitored before and after treatment.

Conditions

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Lichen Planus, Oral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Pimecrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinically and histologically confirmed diagnosis of erosive oral lichen planus
* Spontaneous or meal related oral pain
* No topical therapy 2 weeks prior to study start
* No systemic therapy 4 weeks prior to study start
* Signed informed consent

Exclusion Criteria

* Pregnant or breast-feeding women
* Known allergy to macrolide antibiotics
* Known current active malignant disease or in patient's history
* Known immunodeficiency or HIV infection
* Participation at another clinical trial within the last 6 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Tilo Biedermann, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Tuebingen, Department of Dermatology

Locations

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University Hospital, Department of Dermatology

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CASM981CDE12

Identifier Type: -

Identifier Source: org_study_id