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Efficacy of Elidel Cream on Erosive Oral Lichen Planus

This study has been completed.
Information provided by:
University Hospital Tuebingen Identifier:
First received: August 12, 2005
Last updated: May 21, 2008
Last verified: May 2008
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

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

Secondary Outcome Measures:
  • Patient's and investigator's global assessment after 4 and 8 weeks
  • Pimecrolimus blood level after 4 weeks

Enrollment: 20
Study Start Date: June 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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 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 older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00130572

University Hospital, Department of Dermatology
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Tilo Biedermann, Prof. Dr. med. University of Tuebingen, Department of Dermatology
  More Information Identifier: NCT00130572     History of Changes
Other Study ID Numbers: CASM981CDE12
Study First Received: August 12, 2005
Last Updated: May 21, 2008

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017