Status:
COMPLETED
Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Lichen Planus, Oral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 a...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00130572
Start Date
June 1 2004
End Date
December 1 2007
Last Update
May 23 2008
Active Locations (1)
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1
University Hospital, Department of Dermatology
Tübingen, Germany, 72076