Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Lichen Planus, Oral Clinical Trial

Official title:

Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130572
• Other study ID #: CASM981CDE12
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2005
• Last updated: May 21, 2008
• Start date: June 2004
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral

Intervention

Drug:
• Pimecrolimus

Locations

Country	Name	City	State
Germany	University Hospital, Department of Dermatology	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Secondary	Patient's and investigator's global assessment after 4 and 8 weeks
Secondary	Pimecrolimus blood level after 4 weeks