Lichen Planus, Oral
Conditions
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.
Interventions
DRUGPimecrolimus
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's and investigator's global assessment after 4 and 8 weeks | — |
| Pimecrolimus blood level after 4 weeks | — |
Countries
Germany
Outcome results
None listed