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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus|
- Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
- Patient's and investigator's global assessment after 4 and 8 weeks
- Pimecrolimus blood level after 4 weeks
|Study Start Date:||June 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130572
|University Hospital, Department of Dermatology|
|Tuebingen, Germany, 72076|
|Principal Investigator:||Tilo Biedermann, Prof. Dr. med.||University of Tuebingen, Department of Dermatology|