Pimecrolimus Cream for Oral Lichen Planus

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Christopher Hull, University of Utah
ClinicalTrials.gov Identifier:
NCT00297037
First received: February 23, 2006
Last updated: September 14, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Oral Lichen Planus
Drug: Pimecrolimus 1% cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The Primary Efficacy Variable Was the 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 ]
    The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).


Secondary Outcome Measures:
  • The Secondary Efficacy Variables Was Changes 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 ]
    The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).

  • The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters. [ Time Frame: 0, 1, 2, 4, 6 weeks ] [ Designated as safety issue: No ]
    Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.


Enrollment: 21
Study Start Date: August 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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."
Drug: Pimecrolimus 1% cream
pimecrolimus cream or matching placebo BID for 6 weeks
Other Name: elidel cream
Placebo Comparator: 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."
Drug: Pimecrolimus 1% cream
pimecrolimus cream or matching placebo BID for 6 weeks
Other Name: elidel cream

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Novartis
Investigators
Principal Investigator: Christopher Hull, MD University of Utah
  More Information

Publications:
Responsible Party: Christopher Hull, Associate Professor, Dermatology, University of Utah
ClinicalTrials.gov Identifier: NCT00297037     History of Changes
Other Study ID Numbers: 12589
Study First Received: February 23, 2006
Results First Received: March 1, 2011
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
oral lichen planus, pimecrolimus 1% cream

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014