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.

Condition	Intervention	Phase
Lichen Planus, Oral	Drug: Pimecrolimus	Phase III

Further Study Details: 

Primary Outcomes: Reduction of an 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
Expected Total Enrollment:  20

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Clinical and histological 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00130572

Tilo Biedermann, Prof. Dr. med      + 49 7071 29 80836    tilo.biedermann@med.uni-tuebingen.de

Germany
      University Hospital, Department of Dermatology, Tuebingen,  72076,  Germany; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  CASM981CDE12
Last Updated:  August 12, 2005
Record first received:  August 12, 2005
ClinicalTrials.gov Identifier:  NCT00130572
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-23