Pimecrolimus Cream for Oral Lichen Planus

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborator: Novartis
• Treatments: Pimecrolimus; Tacrolimus

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