Pimecrolimus Cream for Oral Lichen Planus

NCT00297037 | Completed Phase 2 Results

• 1 other identifier: 12589
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Lichen Planus

Keywords

oral lichen planus, pimecrolimus 1% cream

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.

  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).

  0, 1, 2, 4, 6 weeks

Secondary Outcomes (2)

• The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10).

  0, 1, 2, 4, 6 weeks

• The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters.

  0, 1, 2, 4, 6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

"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

2

PLACEBO COMPARATOR

"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

Interventions

Pimecrolimus 1% cream DRUG

pimecrolimus cream or matching placebo BID for 6 weeks

Also known as: elidel cream

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Novartis: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 21175873 RESULT

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Christopher Hull
• Organization: University of Utah

christopher.hull@hsc.utah.edu

801-581-6465

Study Officials

• Christopher Hull, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dermatology

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: August 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 17, 2012
• Results First Posted: October 17, 2012

Record last verified: 2012-06

Locations

US (1)