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Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Primary Purpose

Lichen Planus, Oral

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pimecrolimus
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Planus, Oral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Department of Dermatology

Outcomes

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

Full Information

First Posted
August 12, 2005
Last Updated
May 21, 2008
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00130572
Brief Title
Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Official Title
Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Primary Outcome Measure Information:
Title
Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Secondary Outcome Measure Information:
Title
Patient's and investigator's global assessment after 4 and 8 weeks
Title
Pimecrolimus blood level after 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tilo Biedermann, Prof. Dr. med.
Organizational Affiliation
University of Tuebingen, Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Department of Dermatology
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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Efficacy of Elidel Cream on Erosive Oral Lichen Planus

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