Pimecrolimus Cream for Oral Lichen Planus - Full Text View

Sponsors and Collaborators:	University of Utah Novartis
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00297037

Purpose

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

Condition	Intervention	Phase
Oral Lichen Planus	Drug: Pimecrolimus cream	Phase II

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Week Randomized, Double-Blind, Vehicle-Controlled Pilot Study With a 6-Week Open Label Extension to Assess the Efficacy and Safety of Pimecrolimus 1% Cream in the Treatment of Oral Lichen Planus

Further study details as provided by University of Utah:

Primary Outcome Measures:

The primary efficacy variable will be change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. [ Time Frame: 0, 1, 2, 4, 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary efficacy variables will be changes in the size of the target erosion in millimeters, erythema and assessment of spontaneous pain on a visual analog scale (0-10). [ Time Frame: 0, 1, 2, 4, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	August 2005
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Pimecrolimus cream pimecrolimus cream or matching placebo BID for 6 weeks
2: Placebo Comparator	Drug: Pimecrolimus cream pimecrolimus cream or matching placebo BID for 6 weeks

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 Elidel 1% cream when applied twice daily with occlusion in the treatment of oral lichen planus.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297037

Contacts

Contact: Christopher Hull, MD	8015816465	christopher.hull@hsc.utah.edu
Contact: Katherine Sebastian, MPH	8015816465	krs4@utah.edu

Locations

United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Katherine Sebastian, MPH 801-581-6465

Sponsors and Collaborators

University of Utah

Novartis

Investigators

Principal Investigator:

Christopher Hull, MD

University of Utah

More Information

Responsible Party:	University of Utah ( Christopher Hull, MD )
Study ID Numbers:	US19
Study First Received:	February 23, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00297037
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mouth Diseases
Lichen Planus
Exanthema
Skin Diseases
Pimecrolimus

Oral lichen planus
Stomatognathic Diseases
Skin Diseases, Papulosquamous
Lichen Planus, Oral

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Lichenoid Eruptions
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009