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Efficacy of Elidel Cream on Erosive Oral Lichen Planus

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00130572
First received: August 12, 2005
Last updated: May 21, 2008
Last verified: May 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130572

Locations
Germany
University Hospital, Department of Dermatology
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Tilo Biedermann, Prof. Dr. med. University of Tuebingen, Department of Dermatology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130572     History of Changes
Other Study ID Numbers: CASM981CDE12
Study First Received: August 12, 2005
Last Updated: May 21, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Pimecrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013