Efficacy of Elidel Cream on Erosive Oral Lichen Planus

University Hospital Tuebingen20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lichen Planus, Oral

Interventions

PimecrolimusDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital, Department of Dermatology

Tübingen, Germany

Outcomes

Primary Outcomes

Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment

Secondary Outcomes

Patient's and investigator's global assessment after 4 and 8 weeks

Pimecrolimus blood level after 4 weeks

Data from ClinicalTrials.gov

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