Pimecrolimus Cream for Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Intervention: Pimecrolimus 1% cream
Intervention description: pimecrolimus cream or matching placebo BID for 6 weeks
Intervention MeSH terms: Pimecrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oral lichen planus, pimecrolimus 1% cream

Summary:

      Study investigating the use of pimecrolimus 1% cream for oral lichen planus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Of any gender, 18 years or older.

          -  With a diagnosis of oral lichen planus previously proven on biopsy.

          -  With at least one erosion at baseline (baseline IGA of 2 or greater).

          -  Signed written informed consent.

          -  Willingness and ability to comply with the study requirements.

          -  Negative blood pregnancy tests must be documented for all females of childbearing
             potential prior to enrollment.

        Exclusion Criteria:

          -  Who have received systemic immunosuppressants (e.g. corticosteroids), or oral
             retinoids, or any other systemic therapies known or suspected to have an effect on
             oral lichen planus within 4 weeks prior to participation in the study.

          -  Who have been treated with topical therapy (e.g., topical corticosteroids,
             pimecrolimus, tacrolimus, or topical retinoids, etc) or any other topical therapies
             known or suspected to have an effect on oral lichen planus within two weeks prior to
             participation in the study.

          -  Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an
             evidence of malignant disease.

          -  Who have systemic or generalized infections (bacterial, viral or fungal).

          -  Who have a clinically relevant liver disorder (transaminase enzymes >3 x ULN) or renal
             disorder (serum creatinine > 10% above upper normal limit).

          -  Who have unstable or uncontrolled diabetes or hypertension.

          -  Who are currently receiving or are intended to be treated with any potent inhibitor of
             the enzyme CYP450 3A4. Treatment with substrates or moderately potent inhibitors of
             CYP450 3A4 is permitted during the study, under close monitoring for adverse events
             during that period.

          -  Menstruating females of childbearing potential who are not using a medically accepted
             method of contraception during the study. Medically approved contraception may, at the
             discretion of the investigator, include abstinence.

          -  Women who are breastfeeding.

          -  Who had received an investigational drug within four weeks prior to the study or who
             intended to use other investigational drugs during the course of this study.

          -  Who are hypersensitive to pimecrolimus or any of the components of the cream.

          -  Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study.

          -  Who have a history of substance abuse or any factor, which limits the subject's
             ability to cooperate with the study procedures.

          -  Who are uncooperative, known to miss appointments (according to subjects' records) and
             are unlikely to follow medical instructions or are not willing to attend regular
             visits.

          -  History of Netherton's syndrome

          -  Patients with lymphadenopathy