Pimecrolimus Cream for Oral Lichen Planus

NCT ID: NCT00297037

Last Updated: 2012-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-02-28

Brief Summary

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

Detailed Description

Lichen planus (LP) is an idiopathic inflammatory dermatosis of the skin and mucous membranes. Cutaneous lesions present as pink polygonal papules on the flexor wrists, trunk, thighs, shin and the dorsal hands. Oral lichen planus (OLP) represents a unique subset of LP and is often the sole manifestation of this disease. Clinically, the lesions can be reticulate, erythematous, atrophic or erosive, with the erosive form being the most common. Lesions can be found anywhere in the oral mucosa and are associated with burning pain which is worsened while eating. The risk of development of squamous cell carcinoma has been estimated to be as high as 5%. Treatments for oral lichen planus involve high potency topical steroid, systemic steroids, oral/topical retinoids and immunosuppressants. However, the long term side effects of steroids (e.g. striae, skin atrophy, telangiectasias, tachyphylaxis, secondary candidiasis and perioral dermatitis) prevent more extensive utilization except in the most severe cases. Given the debilitating nature of OLP, risk of malignant transformation, and long term side effects associated with current therapies, a safe intervention is needed for this disorder.

Tacrolimus and pimecrolimus may have fewer side affects than topical steroids. Recently, in an open label trial of 19 patients with recalcitrant erosive lichen planus, tacrolimus decreased the area of ulceration by 73% after an eight week course. Local irritation was the most common side effect. However, tacrolimus comes in an ointment base, a poorly tolerated vehicle for oral lesions. Topical treatment of oral lesions has also been compromised by problems with maintaining sufficient contact time between poorly adherent cream and ointment preparations and moist mucous membrane surfaces.

This study is designed to evaluate the topical application of pimecrolimus 1% cream when applied twice daily with occlusion in the treatment of oral lichen planus.

Conditions

Oral Lichen Planus

Keywords

oral lichen planus, pimecrolimus 1% cream

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."

Group Type: ACTIVE_COMPARATOR

Pimecrolimus 1% cream

Intervention Type: DRUG

pimecrolimus cream or matching placebo BID for 6 weeks

2

"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."

Group Type: PLACEBO_COMPARATOR

Pimecrolimus 1% cream

Intervention Type: DRUG

pimecrolimus cream or matching placebo BID for 6 weeks

Interventions

Pimecrolimus 1% cream

pimecrolimus cream or matching placebo BID for 6 weeks

Intervention Type: DRUG

Other Intervention Names

elidel cream

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Christopher Hull

Associate Professor, Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Hull, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

McCaughey C, Machan M, Bennett R, Zone JJ, Hull CM. Pimecrolimus 1% cream for oral erosive lichen planus: a 6-week randomized, double-blind, vehicle-controlled study with a 6-week open-label extension to assess efficacy and safety. J Eur Acad Dermatol Venereol. 2011 Sep;25(9):1061-7. doi: 10.1111/j.1468-3083.2010.03923.x. Epub 2010 Dec 22.

Reference Type: RESULT

PMID: 21175873 (View on PubMed)

Other Identifiers

12589

Identifier Type: -

Identifier Source: org_study_id