NCT00130572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

3.5 years

First QC Date

August 12, 2005

Last Update Submit

May 21, 2008

Conditions

Lichen Planus, Oral

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Patient's and investigator's global assessment after 4 and 8 weeks

  • Pimecrolimus blood level after 4 weeks

Interventions

PimecrolimusDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Department of Dermatology

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tilo Biedermann, Prof. Dr. med.

    University of Tuebingen, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

June 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 23, 2008

Record last verified: 2008-05

Locations

DE(1)