Clinical Trial: Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Brief Summary: 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 Summary:
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.
Sponsor: University Hospital Tuebingen
Current Primary Outcome: Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Original Primary Outcome: Reduction of an symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Current Secondary Outcome:
- Patient's and investigator's global assessment after 4 and 8 weeks
- Pimecrolimus blood level after 4 weeks
Original Secondary Outcome: Same as current
Information By: University Hospital Tuebingen
Dates:
Date Received: August 12, 2005
Date Started: June 2004
Date Completion:
Last Updated: May 21, 2008
Last Verified: May 2008
