Efficacy of Elidel Cream on Erosive Oral Lichen Planus

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00130572
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.5

Study Details

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.

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 Design

• Study Type: Interventional
• 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: Jun 1, 2004
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00130572
• Other Study ID Numbers: CASM981CDE12
• First Posted: Aug 15, 2005
• Last Update Posted: May 23, 2008
• Last Verified: May 1, 2008

• Additional relevant MeSH terms: Lichen Planus, Oral; Lichen Planus; Pimecrolimus

Study Results

No Results Posted as of May 23, 2008