Official Title: “Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus

Primary Measures

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

Secondary Measures

• Patient's and investigator's global assessment after 4 and 8 weeks
• Pimecrolimus blood level after 4 weeks

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Tuebingen

Overall Clinical Trial Officials and Contacts

Tilo Biedermann, Prof. Dr. med. Principal Investigator University of Tuebingen, Department of Dermatology  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00130572

Study ID Number: CASM981CDE12

ClinicalTrials.gov Identifier: NCT00130572

Health Authority: Germany: Federal Institute for Drugs and Medical Devices