Efficacy of Elidel Cream on Erosive Oral Lichen Planus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130572
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : May 23, 2008
Information provided by:
University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Lichen Planus, Oral Drug: Pimecrolimus Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : June 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00130572     History of Changes
Other Study ID Numbers: CASM981CDE12
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 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