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

August 12, 2005
May 21, 2008
June 2004
December 2007   (final data collection date for primary outcome measure)
Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Reduction of an symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Complete list of historical versions of study NCT00130572 on ClinicalTrials.gov Archive Site
  • Patient's and investigator's global assessment after 4 and 8 weeks
  • Pimecrolimus blood level after 4 weeks
  • Patient’s and investigator’s global assessment after 4 and 8 weeks
  • Pimecrolimus blood level after 4 weeks
Not Provided
Not Provided
 
Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lichen Planus, Oral
Drug: Pimecrolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00130572
CASM981CDE12
Not Provided
Not Provided
University Hospital Tuebingen
Not Provided
Principal Investigator: Tilo Biedermann, Prof. Dr. med. University of Tuebingen, Department of Dermatology
University Hospital Tuebingen
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP